If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Essential Functions • Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program. • Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness • Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns. • Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation. • Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required. • Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate. • Authors or provides guidance for the production of risk management plans (RMPs). • Provides strategic input into regulatory requests / responses. • Delivers clinical safety input into clinical development program. • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications. • Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed. • Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements. • Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team. Required Knowledge, Skills, and Abilities Minimum Requirements • At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management. • Ability to independently search clinical safety and literature databases for relevant information. • Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management. • Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams. • In-depth knowledge of medical and drug terminology, as well as the clinical development process. • Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases. Required/Preferred Education and Licenses Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description This individual will be responsible for leading scientific team members assigned to oncology assets ranging from discovery through regulatory approval. This individual will both manage the oncology pharmacology team and serve a lead on one or more programs themselves. Primary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities. Operational tasks include designing and executing experiments that are outsourced or performed by in-house bench researchers or academic collaborators, reviewing and contributing to clinical protocols, reviewing and authoring technical reports, coauthoring sections of regulatory documents ranging from IND to NDA/BLA submissions, and communicating relevant research at internal and external forums. The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management. Collaborate with and represent ORP on internal teams—to design, develop, implement, and oversee execution of strategies and experiments supporting nonclinical studies in hematologic malignancies and solid tumors. Essential Functions Design and execute experiments to elucidate efficacy, tolerability, mechanism of action, and biomarkers associated with complex combinations of multiple therapeutic modalities (small molecules, biologics, ADCs, bi-specifics, cell therapies, and other emerging platforms). Critically evaluate biochemical and cellular assays. Communicate effectively across JAZZ functional teams, highly matrixed, cross functional environments. Demonstrate strong interpersonal, negotiation, and influence skills. Independently develop experimental strategies, analyze data, and present results to non‑clinical and governance-level teams. Collaborate with CROs to outsource studies, develop protocols, manage timelines and budgets, and partner with academic labs for Jazz sponsored research. Serve as a project team leader and/or as lead pharmacology representative across various oncology programs, Mentor junior scientists and providing scientific leadership and professional growth opportunities. Required Knowledge, Skills, and Abilities Industry experience evaluating therapeutic potential of drug candidates from hit to lead optimization through IND enabling studies, with deep expertise in oncology drug development. Broad background in preclinical oncology with strong familiarity with emerging therapeutic modalities, competitive landscapes, and strategic assessment of diverse drug mechanisms. Extensive experience in Immuno Oncology (I/O), including I/O relevant in vivo and in vitro models, immune cell biology, and integration of immunological endpoints into pharmacology programs. Demonstrated experience working across multiple drug modalities, including small molecules, biologics, ADCs, bi-specifics, T cell engagers, cell and gene therapies, and RNA based therapeutics. Strong foundational understanding of the interdependencies between Nonclinical Pharmacology, Toxicology, DMPK, and Clinical Pharmacology, including how these functions integrate to enable successful dose selection, therapeutic index characterization, risk assessment, and translational strategy. Deep understanding of cancer signaling pathways and their therapeutic exploitation. Proven experience leading multiple complex pharmacology programs at diverse CROs, including GLP and non-GLP environments. Expertise designing and executing studies evaluating efficacy, tolerability, mechanism of action, and biomarker strategies for small molecule and biologic agents. Ability to integrate preclinical and clinical datasets, innovate, and apply novel methodologies to advance therapeutic programs. Proficiency with analytical tools (e.g., GraphPad Prism) and biomarker data analysis. Direct people management experience, including mentorship, performance development, and leadership of scientific teams. Strong leadership qualities, self motivation, and demonstrated success networking across internal teams, academia, industry, and regulatory agencies. Excellent ability to assess program needs, oversee CRO activities, develop/review protocols, monitor execution, interpret results, and prepare high quality reports for regulatory submissions. Experience authoring nonclinical components of IND, NDA/BLA/MAA submissions, briefing packages, DSURs, IBs, and fast track designation documents, with proven ability to ensure alignment and scientific rigor. Strong project management skills with the ability to manage multiple complex programs simultaneously. Demonstrated success leading in fast paced, highly matrixed environments, aligning diverse stakeholders and driving decision making. Strong analytical and creative problem-solving skills. Embody and model Jazz core values. Required/Preferred Education and Licenses Ph.D. in biology, biochemistry, immunology, pharmacology, or a related discipline, with experience leading early oncology programs and developing nonclinical models for characterizing therapeutic efficacy and pharmacodynamics, including substantial oncology and immuno-oncology experience. #LI-SM1 #LI-remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $232,000.00 - $348,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. Essential Functions Job Responsibilities and Requirements: Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s. Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team. Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective. Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling. Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed. Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Participate in or Lead a Safety Management Team (SMT) for an assigned product. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s. Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements. Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data. Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards. Provide safety expertise to due diligence activities, if/ as needed. Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities. Required Knowledge, Skills, and Abilities Minimum Requirements Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. Excellent knowledge of drug development process. Requires a high level of initiative and independence. Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork. Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word. Some national/international travel may be required. Leadership Skills Enterprise and Proactive Mindset—demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment. Set clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP). Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred. Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus. MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus. Ability to manage multiple tasks with deadlines in fast-pace environment. Required/Preferred Education and Licenses MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $256,000.00 - $384,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description The Director, Clinical Development, will join a growing team in the therapeutic areas of Neuroscience. Responsibilities include clinical leadership of development programs, medical monitoring of clinical trials (if MD), contributing to CNS clinical development strategy, supporting regulatory submissions, and representing clinical development in multidisciplinary teams within R Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Sr. Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for the statistical aspects of study design, study analysis and validation, and study documentation. The Principal Statistician will provide timely and scientifically sound statistical expertise to clinical trials and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations. The Principal Statistician will oversee work done by statistics and programming external vendors. Essential Functions Participate in or lead department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies. Work collaboratively with members of study teams to meet study and recurring report timelines. Support the development and implementation of study protocols. Review and provide input to study-specific data capture systems and participate in their validation. Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming. Write statistical analysis plans, perform data analysis and validation, and interpret analyses. Support project lead statistician. Prepare for and attend meetings with regulatory agencies. Respond to statistical questions from regulatory agencies. Work closely with statistical programming colleagues. Monitor CRO guidelines and standards to ensure timeliness and quality of deliverables. Review and validate CRO deliverables. Other work as assigned by line manager. Collaborate as the statistical subject matter expert with medical writers in the production of clinical reports, integrated summaries, and other documents. Learn drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards. Stay current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and other professional development activities. Required Knowledge, Skills, and Abilities Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis. Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus. Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines. Able to work in a fast-paced, flexible, team-oriented environment. Possess excellent interpersonal and communication skills (written and verbal). Strong attention to detail with a view to bring studies to a quality conclusion. Flexible, positive, creative thinker, good communicator. Be able to work without close supervision with effective time management. Minimum Requirements MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry; or PhD in statistics, mathematics, or a related discipline with a statistical focus. Knowledge of drug development regulations pertinent to statistical analysis. Bayesian and adaptive design knowledge is preferred. Proficient SAS Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Senior Principal Real-World Analyst (RWA) will be responsible for conducting analyses for Real-World Evidence (RWE) studies and analytic projects using diverse Real-World Data (RWD) sources including administrative claims, electronic medical records (EMR), and registry data. Reporting to the head of RWD/A, and positioned within the RWE/A, Global Evidence Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and support regulatory filings under the supervision of a more senior statistician. This role is responsible for the statistical aspects of study design, study analysis and validation, and study documentation. The Principal Statistician will provide timely and scientifically sound statistical expertise to clinical trials and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations. The Principal Statistician will oversee work done by statistics and programming external vendors Essential Functions Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies. Work collaboratively with members of study teams to meet study and recurring report timelines. Support the development and implementation of study protocols. Review and provide input to study-specific data capture systems and participate in their validation. Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming. Write statistical analysis plans, perform data analysis and validation, and interpret analyses. Support project lead statistician. Prepare for and attend meetings with regulatory agencies. Respond to statistical questions from regulatory agencies. Work closely with statistical programming colleagues. Monitor CRO guidelines and standards to ensure timeliness and quality of deliverables. Review and validate CRO deliverables. Other work as assigned by line manager. Collaborate as the statistical subject matter expert with medical writers in the production of clinical reports, integrated summaries, and other documents. Learn drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards. Stay current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and other professional development activities. Required Knowledge, Skills, and Abilities Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis. Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus. Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines. Able to work in a fast-paced, flexible, team-oriented environment. Possess excellent interpersonal and communication skills (written and verbal). Strong attention to detail with a view to bring studies to a quality conclusion. Flexible, positive, creative thinker, good communicator. Be able to work without close supervision with effective time management. Required/Preferred Education and Licenses MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in pharmaceutical or biotechnology industry. PhD in statistics, mathematics, or a related discipline with a statistical focus and Knowledge of drug development regulations pertinent to statistical analysis. Bayesian and adaptive design knowledge is preferred. Proficient SAS Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Associate Director, Medical Safety (Scientist) is a key member of the Medical Safety team. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Essential Functions • Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program. • Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness • Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns. • Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation. • Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required. • Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate. • Authors or provides guidance for the production of risk management plans (RMPs). • Provides strategic input into regulatory requests / responses. • Delivers clinical safety input into clinical development program. • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications. • Participates in and/or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners, as needed. • Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements. • Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team. Required Knowledge, Skills, and Abilities Minimum Requirements • At least 6 years of experience in drug safety, including at least 4 years of experience in surveillance / risk management. • Ability to independently search clinical safety and literature databases for relevant information. • Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management. • Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams. • In-depth knowledge of medical and drug terminology, as well as the clinical development process. • Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases. Required/Preferred Education and Licenses Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline and experience. #LI - Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $156,000.00 - $234,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: This person will join the R Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation. The Senior Principal Statistician will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations. The Senior Principal Statistician will manage work done by statistics and programming external vendors. Essential Functions Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols. Collaborate with cross-functional team members to meet study any recurring report timelines. Support the development and implementation of study protocols. Review and provide input to data capture systems and participate in their validation. Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming. Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses. Prepare for and attend meetings with regulatory agencies. Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices. Review timelines and analysis plans for CRO work to ensure timeliness and quality deliveries. Review and validate CRO deliverables. Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents. Respond to statistical questions from regulatory agencies. Required Knowledge, Skills, and Abilities Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis. Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus. Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards. Able to work in a fast-paced, flexible, team-oriented environment. Possess excellent interpersonal and communication skills (written and verbal). Strong attention to detail with a view to bring studies to a quality conclusion. Flexible, positive, creative thinker, good communicator. Work without close supervision. Well-developed time management skills are important. Required/Preferred Education and Licenses MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry. PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry. Knowledge of drug development regulations pertinent to statistical analysis. Knowledge of the oncology or hematology therapeutic area is preferred Bayesian and adaptive design experience is preferred. Proficient SAS Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. 1 Essential Functions/Responsibilities The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle. This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. • Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence • Provide Medical safety/PV inputs to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products • Participate in the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts, journal articles and other documents as needed, ensuring safety profile reflected for assigned products • Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and with the Jazz Labeling Committee ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling • Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed • Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders • Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums for assigned products • Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products • Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements • Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections • Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company’s goals • Contribute to key performance indicators to ensure PV excellence • Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities 2 Required Knowledge, Skills, and Abilities • Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas and European Union, territories including an understanding of case processing procedures and other pharmacovigilance processes • Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems • MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries • Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred • Ability to manage multiple tasks with deadlines in fast-paced working environment • Knowledge of drug development process • Requires a high level of initiative and independence • Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork • Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word • Some national/international travel may be required 3 Required/Preferred Education and Licenses • MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus • Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $212,000.00 - $318,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Senior Clinical Data Manager will be responsible for performing Data Management activities that support Jazz Pharmaceuticals’ commercial and development projects worldwide. You will p articipate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance. ​ ​ Be able to lead a complex clinical study or a series of related studies with minimal guidance. Essential Functions/Responsibilities ​ Represents Data Management on the study team for assigned studies. ​ Manage and monitor the progress of data management activities and vendors on assigned studies. Manage and monitor CRO progress for outsourced studies. B uild effective relationships with CRO / vendor counterparts. ​ Review protocols for appropriate data capture requirements including electronic Case Report Form (eCRF) design and electronic Clinical Outcome Assessments ( eCOA ) forms . ​ Interact with study team members e.g., CRAs, programmers, CTMs and statisticians in designing eCRFs and CRF completion guidelines. ​ Lead the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members. ​ Support the development of other system set- up e.g., eCOA and Interactive Response Technology (IRT). ​ Lead the development of data edit check specifications and data listings and run data listings as required . ​ Develop or lead the development of the Data Management documents for a clinical study. ​ Able to review and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans, Statistical analysis plans and vendor specifications. ​ P rovide training on the EDC and/or eCOA system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed. ​ Lead database upgrades/migrations including performing User Acceptance Testing. ​ Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries. ​ Perform reconciliation of data from external data sources against the clinical database . ​ Perform Serious Adverse Event reconciliation activities. ​ Perform database freeze and lock activities. ​ Be able to maintain study eTMF. ​ Participate in the generation of study timelines and manage DM activities against the timelines. ​ Provide mentoring and training to junior level Data Management staff assigned to his/her studies. ​ Assist with the onboarding and/or training of new employees and/or contractors. ​ Participate in regular Clinical Data Operations team meetings and provide input when appropriate . ​ Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents. ​ Contribute to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics Essential Functions/Responsibilities Be able to lead a complex clinical study or a series of related studies with minimal guidance. Represents Data Management on the study team for assigned studies. Manage and monitor the progress of data management activities and vendors on assigned studies. Manage and monitor CRO progress for outsourced studies. Build effective relationships with CRO / vendor counterparts. Review protocols for appropriate data capture requirements including electronic Case Report Form (eCRF) design and electronic Clinical Outcome Assessments (eCOA) forms. Interact with study team members e.g., CRAs, programmers, CTMs and statisticians in designing eCRFs and CRF completion guidelines. Lead the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members. Support the development of other system set-up e.g., eCOA and Interactive Response Technology (IRT). Lead the development of data edit check specifications and data listings and run data listings as required. Develop or lead the development of the Data Management documents for a clinical study. Able to review and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans, Statistical analysis plans and vendor specifications. Provide training on the EDC and/or eCOA system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed. Lead database upgrades/migrations including performing User Acceptance Testing. Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries. Perform reconciliation of data from external data sources against the clinical database. Perform Serious Adverse Event reconciliation activities. Perform database freeze and lock activities. Be able to maintain study eTMF. Participate in the generation of study timelines and manage DM activities against the timelines. Provide mentoring and training to junior level Data Management staff assigned to his/her studies. Assist with the onboarding and/or training of new employees and/or contractors. Participate in regular Clinical Data Operations team meetings and provide input when appropriate. Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents. Contribute to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics Required Knowledge, Skills, and Abilities Experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience. Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors. Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. Has good project management skills and a proven ability to prioritize across multiple tasks. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Experience working with a globally distributed team. Good communication/interaction skills and ability to work in a dynamic and growing organization. Experience of Risk Based Monitoring principles and using critical thinking to assess and manage risk on assigned studies. Possesses strong English language written and verbal communication skills. Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable. Able to travel to off-site meetings or training seminars as needed. Required/Preferred Education and Licenses BA/BS, preferably in the scientific/healthcare field #LI-SM1 #LI-remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Essential Functions • Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program. • Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness • Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns. • Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation. • Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required. • Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate. • Authors or provides guidance for the production of risk management plans (RMPs). • Provides strategic input into regulatory requests / responses. • Delivers clinical safety input into clinical development program. • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications. • Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed. • Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements. • Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team. Required Knowledge, Skills, and Abilities Minimum Requirements • At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management. • Ability to independently search clinical safety and literature databases for relevant information. • Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management. • Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams. • In-depth knowledge of medical and drug terminology, as well as the clinical development process. • Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases. Required/Preferred Education and Licenses Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Essential Functions • Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program. • Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness • Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns. • Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation. • Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required. • Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate. • Authors or provides guidance for the production of risk management plans (RMPs). • Provides strategic input into regulatory requests / responses. • Delivers clinical safety input into clinical development program. • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications. • Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed. • Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements. • Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team. Required Knowledge, Skills, and Abilities Minimum Requirements • At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management. • Ability to independently search clinical safety and literature databases for relevant information. • Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management. • Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams. • In-depth knowledge of medical and drug terminology, as well as the clinical development process. • Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases. Required/Preferred Education and Licenses Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. 1 Essential Functions/Responsibilities The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle. This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. • Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence • Provide Medical safety/PV inputs to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products • Participate in the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts, journal articles and other documents as needed, ensuring safety profile reflected for assigned products • Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and with the Jazz Labeling Committee ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling • Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed • Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders • Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums for assigned products • Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products • Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements • Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections • Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company’s goals • Contribute to key performance indicators to ensure PV excellence • Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities 2 Required Knowledge, Skills, and Abilities • Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas and European Union, territories including an understanding of case processing procedures and other pharmacovigilance processes • Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems • MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries • Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred • Ability to manage multiple tasks with deadlines in fast-paced working environment • Knowledge of drug development process • Requires a high level of initiative and independence • Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork • Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word • Some national/international travel may be required 3 Required/Preferred Education and Licenses • MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus • Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $212,000.00 - $318,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. Essential Functions Job Responsibilities and Requirements: Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s. Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team. Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective. Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling. Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed. Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Participate in or Lead a Safety Management Team (SMT) for an assigned product. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s. Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements. Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data. Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards. Provide safety expertise to due diligence activities, if/ as needed. Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities. Required Knowledge, Skills, and Abilities Minimum Requirements Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. Excellent knowledge of drug development process. Requires a high level of initiative and independence. Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork. Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word. Some national/international travel may be required. Leadership Skills Enterprise and Proactive Mindset—demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment. Set clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP). Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred. Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus. MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus. Ability to manage multiple tasks with deadlines in fast-pace environment. Required/Preferred Education and Licenses MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $256,000.00 - $384,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. 1 Essential Functions/Responsibilities The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle. This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. • Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence • Provide Medical safety/PV inputs to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products • Participate in the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts, journal articles and other documents as needed, ensuring safety profile reflected for assigned products • Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and with the Jazz Labeling Committee ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling • Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed • Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders • Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums for assigned products • Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products • Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements • Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections • Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company’s goals • Contribute to key performance indicators to ensure PV excellence • Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities 2 Required Knowledge, Skills, and Abilities • Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas and European Union, territories including an understanding of case processing procedures and other pharmacovigilance processes • Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems • MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries • Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred • Ability to manage multiple tasks with deadlines in fast-paced working environment • Knowledge of drug development process • Requires a high level of initiative and independence • Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork • Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word • Some national/international travel may be required 3 Required/Preferred Education and Licenses • MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus • Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $212,000.00 - $318,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. Essential Functions Job Responsibilities and Requirements: Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s. Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team. Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective. Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling. Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed. Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Participate in or Lead a Safety Management Team (SMT) for an assigned product. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s. Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements. Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data. Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards. Provide safety expertise to due diligence activities, if/ as needed. Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities. Required Knowledge, Skills, and Abilities Minimum Requirements Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. Excellent knowledge of drug development process. Requires a high level of initiative and independence. Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork. Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word. Some national/international travel may be required. Leadership Skills Enterprise and Proactive Mindset—demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment. Set clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP). Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred. Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus. MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus. Ability to manage multiple tasks with deadlines in fast-pace environment. Required/Preferred Education and Licenses MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $256,000.00 - $384,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Senior Clinical Data Manager will be responsible for performing Data Management activities that support Jazz Pharmaceuticals’ commercial and development projects worldwide. You will p articipate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance. ​ ​ Be able to lead a complex clinical study or a series of related studies with minimal guidance. Essential Functions/Responsibilities ​ Represents Data Management on the study team for assigned studies. ​ Manage and monitor the progress of data management activities and vendors on assigned studies. Manage and monitor CRO progress for outsourced studies. B uild effective relationships with CRO / vendor counterparts. ​ Review protocols for appropriate data capture requirements including electronic Case Report Form (eCRF) design and electronic Clinical Outcome Assessments ( eCOA ) forms . ​ Interact with study team members e.g., CRAs, programmers, CTMs and statisticians in designing eCRFs and CRF completion guidelines. ​ Lead the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members. ​ Support the development of other system set- up e.g., eCOA and Interactive Response Technology (IRT). ​ Lead the development of data edit check specifications and data listings and run data listings as required . ​ Develop or lead the development of the Data Management documents for a clinical study. ​ Able to review and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans, Statistical analysis plans and vendor specifications. ​ P rovide training on the EDC and/or eCOA system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed. ​ Lead database upgrades/migrations including performing User Acceptance Testing. ​ Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries. ​ Perform reconciliation of data from external data sources against the clinical database . ​ Perform Serious Adverse Event reconciliation activities. ​ Perform database freeze and lock activities. ​ Be able to maintain study eTMF. ​ Participate in the generation of study timelines and manage DM activities against the timelines. ​ Provide mentoring and training to junior level Data Management staff assigned to his/her studies. ​ Assist with the onboarding and/or training of new employees and/or contractors. ​ Participate in regular Clinical Data Operations team meetings and provide input when appropriate . ​ Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents. ​ Contribute to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics Essential Functions/Responsibilities Be able to lead a complex clinical study or a series of related studies with minimal guidance. Represents Data Management on the study team for assigned studies. Manage and monitor the progress of data management activities and vendors on assigned studies. Manage and monitor CRO progress for outsourced studies. Build effective relationships with CRO / vendor counterparts. Review protocols for appropriate data capture requirements including electronic Case Report Form (eCRF) design and electronic Clinical Outcome Assessments (eCOA) forms. Interact with study team members e.g., CRAs, programmers, CTMs and statisticians in designing eCRFs and CRF completion guidelines. Lead the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members. Support the development of other system set-up e.g., eCOA and Interactive Response Technology (IRT). Lead the development of data edit check specifications and data listings and run data listings as required. Develop or lead the development of the Data Management documents for a clinical study. Able to review and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans, Statistical analysis plans and vendor specifications. Provide training on the EDC and/or eCOA system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed. Lead database upgrades/migrations including performing User Acceptance Testing. Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries. Perform reconciliation of data from external data sources against the clinical database. Perform Serious Adverse Event reconciliation activities. Perform database freeze and lock activities. Be able to maintain study eTMF. Participate in the generation of study timelines and manage DM activities against the timelines. Provide mentoring and training to junior level Data Management staff assigned to his/her studies. Assist with the onboarding and/or training of new employees and/or contractors. Participate in regular Clinical Data Operations team meetings and provide input when appropriate. Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents. Contribute to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics Required Knowledge, Skills, and Abilities Experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience. Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors. Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. Has good project management skills and a proven ability to prioritize across multiple tasks. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Experience working with a globally distributed team. Good communication/interaction skills and ability to work in a dynamic and growing organization. Experience of Risk Based Monitoring principles and using critical thinking to assess and manage risk on assigned studies. Possesses strong English language written and verbal communication skills. Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable. Able to travel to off-site meetings or training seminars as needed. Required/Preferred Education and Licenses BA/BS, preferably in the scientific/healthcare field #LI-SM1 #LI-remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Associate Director, Medical Safety (Scientist) is a key member of the Medical Safety team. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Essential Functions • Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program. • Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness • Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns. • Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation. • Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required. • Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate. • Authors or provides guidance for the production of risk management plans (RMPs). • Provides strategic input into regulatory requests / responses. • Delivers clinical safety input into clinical development program. • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications. • Participates in and/or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners, as needed. • Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements. • Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team. Required Knowledge, Skills, and Abilities Minimum Requirements • At least 6 years of experience in drug safety, including at least 4 years of experience in surveillance / risk management. • Ability to independently search clinical safety and literature databases for relevant information. • Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management. • Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams. • In-depth knowledge of medical and drug terminology, as well as the clinical development process. • Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases. Required/Preferred Education and Licenses Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline and experience. #LI - Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $156,000.00 - $234,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Please note this is a site based position in Kent Science Park. The Process Technician Senior Coordinator is responsible for processing refined extract and its intermediates using a series of well-defined and documented manufacturing processes/procedures whilst being in compliance with Health and Safety (H Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Biologics Drug Substance Senior Quality Assurance Specialist is Responsible for performing key Quality tasks in respect of Company Biologics products. Work in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations, as well as Internal Quality Systems. Reporting directly to the Drug Substance Lead, External Manufacturing QA. Essential Functions/Responsibilities The position is responsible for monitoring and supporting the quality performance of contract manufacturing organisations and material suppliers to all applicable GXP standards. Responsible for, but not limited to: Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product related investigations. CMO Batch file and product testing record review and approval. Associated lot Disposition activity. Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations Collaboration with all contract manufacturers, packagers and testing laboratories to resolve any quality issues. Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, as required. Highlighting any risks associated with maintaining supply of commercial drug products to all markets. Conducting vendor audits and vendor site visits as required. Assisting in internal audits and regulatory agency inspections. Summarizing CMO Annual Product Quality Reviews and supporting regulatory submissions Assist with the generation of Jazz APQR (Annual Product Quality Review). Maintaining product related Quality Technical Agreements (QTAs). Understanding new regulations and guidelines, as they apply to the company business and implement systems and procedures to incorporate these new regulations as appropriate. Review and approve moderate complexity deviations and associated corrective actions. Support the generation of new, as well as improvement of, existing department SOPs. Support delivery of projects. Work with management to resolve project issues and resource constraints within the team. Liaise with the internal and external stakeholders to resolve and clarify any point of issue. Review and approve less complex validation documents. Partner with other departments/groups to problem-solve and address moderately complex issues. Collaborate in the continuous improvement of the QA processes, identifying opportunities and leading them up to the implementation. Represent QA in cross-functional project teams for moderately difficult projects. Participate in and facilitate regulatory inspection readiness. Coordinates and collaborates with other teams to meet organizational goals and work requirements. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; solves moderately complex problems and can identify viable and often innovative options. Uses analytical skills and judgment to recommend the "best" solution. Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations. Maintain quality from cell banking through to production and post-release events (e.g., stability, product complaints). Required Knowledge, Skills, and Abilities Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry. Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, deep knowledge of Biologics manufacturing. Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site. Experience with contract manufacturing is desirable. Significant experience (>5years) of commercial and/or late state clinical phase GMP manufacturing of biologics. Highly organised, with exceptional time management and prioritization. Excellent verbal and written communication skills. Experience in Drug Product Manufacture in addition to Drug Substance an advantage QP eligibility or progress toward QP certification is highly desirable. Required/Preferred Education and Licenses Bachelor’s degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology or a related discipline Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: To assist the Quality Compliance Manager and other QA team members in the implementation of the Quality Systems at the KSP facility and associated contractor sites. Essential Functions Key Responsibilities / Accountabilities Managing and maintaining of the quality management system: Corrective and preventative actions (CAPA) Deviations Change control Supplier and customer complaints Quality risk management (QRM) Leading root cause analysis (RCA) Liaising with global process owners to ensure consistency in the QMS between sites and functions Training in the QMS Collating QMS metrics and KPI data Presenting QMS data at quality management review (QMR) meetings Quality Vendor Management New Supplier/Vendor onboarding Internal and External Audit management Detailed Responsibilities / Accountabilities Prepares, reviews, updates and completes QMS processes Ensures training records are kept up to date Carries out their work in a way that will not adversely affect their own, or others’ health, safety and security or the environment and reports any shortcomings in GW arrangements Ensure all complaints are documented, investigated and closed out within agreed guidelines. That issues are escalated as required Strives to ensure quality events are closed within agreed timeframes and facilitates management of quality events across KSP Assisting in the assembly of the product quality review Ensuring that regulatory, marketing partners due diligence and other audit/inspections performed at GW are supported with efficient document retrieval and supply of the technical information Management of quality qualifications and approval of vendor to ensure compliance to regulations. Ensures vendors are maintained and monitored using a risk-based approach which links into the external auditing process and the business. Lead and support internal and external audits, report write up and response management. Assist in the creation of technical agreements, supplier agreements and quality risk assessments Participate or leads projects to deliver improvements in productivity and efficiency in all areas relevant to complaints Authors and reviews all required quality documents Creates training packages for QMS process at KSP Authors and edits SOPs associated with the QMS at KSP Required Knowledge, Skills, and Abilities Skills: Working knowledge of office IT packages High level of written and verbal communication skills Attributes and Behaviors: Motivated individuals that have extensive experience across many disciplines within the pharmaceutical industry and have spent a significant period of time within quality assurance, demonstrating the ability to develop quality systems. Required / Preferred Education and Licenses Education: Typically, Bachelor’s degree (or equivalent) in science or related discipline Post-graduate qualifications (Master’s, PhD) preferred Experience: Extensive work experience in the Pharmaceutical, Biotechnology or a related industry Experience working within a quality environment, including experience in GMP, GACP and GDP #LI-SP1 #LI-onsite Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Process Technician Coordinator is responsible for all manufacturing and packaging processes with Botanical Drug Product (BDP) using a series of well-defined and documented manufacturing procedures whilst being in compliance with Health and Safety (H Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Associate Director, Medical Safety (Scientist) is a key member of the Medical Safety team. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Essential Functions • Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program. • Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness • Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns. • Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation. • Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required. • Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate. • Authors or provides guidance for the production of risk management plans (RMPs). • Provides strategic input into regulatory requests / responses. • Delivers clinical safety input into clinical development program. • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications. • Participates in and/or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners, as needed. • Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements. • Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team. Required Knowledge, Skills, and Abilities Minimum Requirements • At least 6 years of experience in drug safety, including at least 4 years of experience in surveillance / risk management. • Ability to independently search clinical safety and literature databases for relevant information. • Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management. • Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams. • In-depth knowledge of medical and drug terminology, as well as the clinical development process. • Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases. Required/Preferred Education and Licenses Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline and experience. #LI - Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $156,000.00 - $234,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. ​ ​ Reporting into the Snr Director Analytical Development, this is an opportunity to join the Small Molecule Development team within Jazz Pharmaceuticals. The role will provide scientific and technical leadership for analytical development at various stages of drug development both internal and external through CDMO with particular emphasis on research and early development (pre-DP0) including material characterization, analytical method assessment, forced degradation development, transfer, validation and tr oubleshooting of methods. The position will lead analytical activities for research/early development programs and late stage development programs . Activities may be performed internally or with external vendors. Other responsibilities will include cross-functional team membership and/or leadership , authoring and/or reviewing method validation protocols and reports, technical reports, authoring or reviewing CMC aspects of regulatory dossiers and participation in department or functional initiatives . The role will play a key part in shaping analytical strategies prior to DP0 and during IND enabling activities , where speed, pragmatism and phase-appropriate control strategies are critical. ​ ​ The role will involve significant cross functional collaboration with other functions including Quality, CMC Regulatory, Manufacturing, and New Product Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Batch Processing Record Reviewer is responsible for ensuring all batches processed in B750 Extraction Facility have Batch Manufacturing Records completed in compliance with requirements. This requires all processing steps to have been completed and documented with respect to ALCOA+ principles and all Critical Process Parameters (CPPs) having been met prior to approving the manufacturing review. Any deficiencies must be documented and where appropriate deviations raised and referenced. The Job Holder must ensure compliance with Health and Safety (H Read Less

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Essential Functions • Support the development and implementation of AI/ML/GenAI solutions to optimize clinical trial operations, including such areas as patient recruitment, patient retention, real - time data monitoring and automated data collection system build. • Support the development and implementation GenAI applications for automated clinical trial documentation generation including such areas medical reports, clinical study reports, protocols and patient narratives. • Support the development and implementation of Digital Healthcare applications for medical and scientific tools, RWE new ways of generating real data, patients’ engagement. • Support the design and develop predictive models and generative AI solutions using diverse healthcare data sources, including clinical trials data, electronic health records, wearable devices, patient - reported outcomes, HEOR data, phase IV studies. • Ensuring compliance with regulatory requirements and data privacy standards. Required Knowledge, Skills and Abilities • Strong programming skills in Python, R, or similar languages, with experience in modern ML frameworks (PyTorch, TensorFlow). • Demonstrated experience with generative AI technologies, including LLM architectures and frameworks. • Knowledge/experience with digital healthcare tools design and development • Experience with natural language processing and generative AI for medical text analysis, generation, and interpretation. • Demonstrated ability to build relationships with stakeholders and subject matter experts. •Familiarity with high compute cloud-based platforms and services, in particular AWS. •Familiarity with code version control and MLOps deployment approaches. Required/Preferred Education and Licenses •Advanced degree (MS or PhD) in Data Science, Computer Science, Biostatistics, or related field •3 – 5 years of related professional experience, with 1+ years of experience applying AI/ML techniques to healthcare or clinical research data. •Experience in healthcare/AI implementation in healthcare field is a plus. •Knowledge of digital healthcare tools design and development #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less

Veterinary Surgeon Permanent, Full-time 35500 - 90000 Take your Veterinary career to new heights with Vets for Pets Embark on an exciting journey with a team that not only values your expertise but celebrates your passion for animal care! At Vets for Pets, we re always on the lookout for talented Veterinary Surgeons to join our fantastic teams on a nationwide basis. Do you have a passion for general practice, have exceptional customer service and communication skills, and a genuine desire to provide the best care for pets and their devoted owners? If you answered yes, we want to hear from you! About Us With over 440 small animal practices across the UK, our practices are as unique as the communities they serve. Each clinic is independently run by passionate practice owners and every pet we see benefits from personalised care supported by the latest technology, not to mention the gentle touch of our expert vet teams. This means you won't find two practices alike, and you'll immediately become part of a welcoming local network and team. What We Offer At Vets for Pets, it s more than just a job. We offer all the benefits you d expect from a major employer (pension, healthcare, CPD allowance, paid memberships, competitive salary up to 90,000doe) plus a few more, such as excellent career progression and funding for certificates, exclusive lifestyle and shopping discounts (up to 30% off at Pets at Home), and relocation packages from within or outside the UK, including visa sponsorship (we re an A rated sponsor). Work-Life Balance Tailored for You We understand the importance of balance. Whether you're looking for full-time or part-time work, we can create a bespoke work pattern that suits your needs. We can also cater to your strengths and interests so if you want a consult only role or are strong in surgery, we can find the right practice for you. Inclusivity Is Our Strength At Vets for Pets, we see people just as pets see them without judgment. We embrace diversity and work tirelessly to break down barriers, attract and develop diverse talent, and foster a culture where everyone can thrive. Regardless of your background or circumstances, you are welcome here. Your future with Vets for Pets awaits! Read Less

Veterinary Surgeon Permanent, Full-time 35500 - 90000 Take your Veterinary career to new heights with Vets for Pets Embark on an exciting journey with a team that not only values your expertise but celebrates your passion for animal care! At Vets for Pets, we re always on the lookout for talented Veterinary Surgeons to join our fantastic teams on a nationwide basis. Do you have a passion for general practice, have exceptional customer service and communication skills, and a genuine desire to provide the best care for pets and their devoted owners? If you answered yes, we want to hear from you! About Us With over 440 small animal practices across the UK, our practices are as unique as the communities they serve. Each clinic is independently run by passionate practice owners and every pet we see benefits from personalised care supported by the latest technology, not to mention the gentle touch of our expert vet teams. This means you won't find two practices alike, and you'll immediately become part of a welcoming local network and team. What We Offer At Vets for Pets, it s more than just a job. We offer all the benefits you d expect from a major employer (pension, healthcare, CPD allowance, paid memberships, competitive salary up to 90,000doe) plus a few more, such as excellent career progression and funding for certificates, exclusive lifestyle and shopping discounts (up to 30% off at Pets at Home), and relocation packages from within or outside the UK, including visa sponsorship (we re an A rated sponsor). Work-Life Balance Tailored for You We understand the importance of balance. Whether you're looking for full-time or part-time work, we can create a bespoke work pattern that suits your needs. We can also cater to your strengths and interests so if you want a consult only role or are strong in surgery, we can find the right practice for you. Inclusivity Is Our Strength At Vets for Pets, we see people just as pets see them without judgment. We embrace diversity and work tirelessly to break down barriers, attract and develop diverse talent, and foster a culture where everyone can thrive. Regardless of your background or circumstances, you are welcome here. Your future with Vets for Pets awaits! Read Less