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 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: 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 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 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. 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 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: 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. 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. 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. 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. 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. ​ ​ 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. 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

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: 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

Finance Director - Manufacturing Location: Onsite - Liverpool, United Kingdom Role Overview The Manufacturing Finance Director will play a critical role in driving value creation within a private equity–backed manufacturing business. Acting as a trusted partner to the Managing Director and senior leadership team, the role is responsible for financial strategy, operational finance, and performance improvement, with a strong focus on EBITDA growth, cash generation, and scalable financial controls. This is a hands-on leadership role suited to a commercially minded finance leader who thrives in a fast-paced, results-driven environment. Key Responsibilities Manufacturing Finance licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. With that said, as required by local law, Vaco by Highspring believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure. The individual may also be eligible for discretionary bonuses. Read Less

Recruitment Incentive: Applicants may be eligible for a $40,000 recruitment incentive in accordance with regulatory requirements. Click apply for complete details on the recruitment incentive details and eligibility. At their core, those who join the Secret Service are courageous, intelligent, strong and determined. A diverse team capable of balancing our investigative mission and fulfilling our protective legacy. Proven to be worthy of trust and confidence. Be tomorrow's Secret Service. During the course of their careers, special agents carry out assignments in both investigations and protection and may be assigned to multiple duty stations throughout the U.S. and abroad. Duties include: Providing protection for various protectees. Conducting criminal investigations pertaining to financial obligations of the United States. Planning and implementing security designs for National Special Security Events. This is no ordinary job, and our special agents are no ordinary individuals. Show us you have the talent and background we need, and we'll show you the rewards that come with being a special agent in the U.S. Secret Service. We invite you to become part of our elite team. Explore a career that will take you to new heights while you serve your country with honor, distinction and pride. Requirements U.S. citizenship is required Possess a current valid driver's license Carry and use a firearm. Maintaining firearm proficiency is mandatory. Be at least age 21 at the time of application and less than age 37 at the time you receive a conditional offer of employment, unless you have previous service in a Federal Civilian Law Enforcement position covered by special law enforcement or firefighter retirement provisions, including early or mandatory retirement. Applicants with veteran's preference must receive a conditional offer of employment prior to reaching age 40 to continue in the application process. You must obtain a Top Secret Clearance and retain it during your career. Possess uncorrected visual acuity of no worse than 20/100 binocular, possess corrected visual acuity of 20/20 or better in each eye. Hearing loss, as measured by an audiometer, must not exceed 25 decibels (A.S.A. or equivalent I.S.O.) in either ear in the 500,1000 and 2000Hz ranges. Submit to a drug test prior to your appointment and random drug testing while you occupy the position. Complete 13 weeks of intensive training at the Federal Law Enforcement Training Center(FLETC) in Glynco, GA and 18 weeks of specialized training at the James J. Rowley Training Center in Laurel, MD. Sign a mobility agreement stating your willingness to accept assignments anywhere within the United States and overseas. Certify that you have registered with the Selective Service System or are exempt from having to do so, if you are a male applicant born after December 31, 1959. Read Less

Recruitment Incentive: Applicants may be eligible for a $40,000 recruitment incentive in accordance with regulatory requirements. Click apply for complete details on the recruitment incentive details and eligibility. At their core, those who join the Secret Service are courageous, intelligent, strong and determined. A diverse team capable of balancing our investigative mission and fulfilling our protective legacy. Proven to be worthy of trust and confidence. Be tomorrow's Secret Service. During the course of their careers, special agents carry out assignments in both investigations and protection and may be assigned to multiple duty stations throughout the U.S. and abroad. Duties include: Providing protection for various protectees. Conducting criminal investigations pertaining to financial obligations of the United States. Planning and implementing security designs for National Special Security Events. This is no ordinary job, and our special agents are no ordinary individuals. Show us you have the talent and background we need, and we'll show you the rewards that come with being a special agent in the U.S. Secret Service. We invite you to become part of our elite team. Explore a career that will take you to new heights while you serve your country with honor, distinction and pride. Requirements U.S. citizenship is required Possess a current valid driver's license Carry and use a firearm. Maintaining firearm proficiency is mandatory. Be at least age 21 at the time of application and less than age 37 at the time you receive a conditional offer of employment, unless you have previous service in a Federal Civilian Law Enforcement position covered by special law enforcement or firefighter retirement provisions, including early or mandatory retirement. Applicants with veteran's preference must receive a conditional offer of employment prior to reaching age 40 to continue in the application process. You must obtain a Top Secret Clearance and retain it during your career. Possess uncorrected visual acuity of no worse than 20/100 binocular, possess corrected visual acuity of 20/20 or better in each eye. Hearing loss, as measured by an audiometer, must not exceed 25 decibels (A.S.A. or equivalent I.S.O.) in either ear in the 500,1000 and 2000Hz ranges. Submit to a drug test prior to your appointment and random drug testing while you occupy the position. Complete 13 weeks of intensive training at the Federal Law Enforcement Training Center(FLETC) in Glynco, GA and 18 weeks of specialized training at the James J. Rowley Training Center in Laurel, MD. Sign a mobility agreement stating your willingness to accept assignments anywhere within the United States and overseas. Certify that you have registered with the Selective Service System or are exempt from having to do so, if you are a male applicant born after December 31, 1959. Read Less

Account Manager, MP Services SALARY: £34,110 - 37,110 per annum LOCATION: Hybrid United Kingdom (multiple locations) - England Scotland Northern Ireland Wales London. We're a fully hybrid organisation, with colleagues across all corners of the UK JOB TYPE: Full-Time, Permanent WORKING HOURS: 36 Hours per Week Job Description IPSA has a clear vision; to regulate through an exemplary, seamless service. MP Services is at the heart of IPSA, offering vital support to MPs and their staff to ensure they can access the funding they need to do their parliamentary and constituency work. The MP Services team provides principles-based support on a wide range of services from budget management to property to ensure MPs comply with IPSA s regulatory principles. The Account Manager regulates through service, providing support and guidance to a cohort of MPs and their staff on budget management, funding decisions, property and running an effective office. The role simplifies complexity and enables MPs and their staff to make confident, principles-based decisions, challenging constructively and escalating concerns appropriately. As part of a dynamic team of up to 20 Account Managers, the role works collaboratively through a matrix structure with IPSA s Payroll Services, Service Quality, Finance Business Partnering and Standards teams to ensure joined-up support and to identify trends and risks. The role holder will live IPSA s values, lead by example and collaborate with, support and challenge others to ensure IPSA remains a great place to work and MP and MP Staff satisfaction is high. Key responsibilities Providing exemplary, seamless principles-based support to MPs and their staff, ensuring a joined up, consistently high-quality service aligned with IPSA s values, educating MPs and their staff on IPSA s systems and processes to support trust in democracy and assure the public. Managing day-to-day requests within challenging SLAs, ensuring MPs have access to the right support, services and information when they need it. Providing expert support to MPs and their staff on accessing funding, budget management, and property rental registration, enabling them to make sound, principles-based decisions. Contributing to continuous improvements, helping to shape and test new services and processes and embracing changes that impact MPs and their staff to minimise disruption. Building trusting, effective relationships with a cohort of MPs and their staff, understanding and anticipating their needs, spending patterns and challenges to provide timely, tailored high-quality support. Acting as the first line of defence by identifying and addressing risks early, constructively and sensitively challenging decisions that may fall outside IPSA s principles, and escalating concerns, where appropriate. Collaborating with internal and external stakeholders to provide joined-up, efficient customer service. Reflecting IPSA s core values of Staying Connected, Seeing the Bigger Picture, Being Open, Doing the Right Thing and Making a Difference through all that you do. IPSA is a learning organisation. We constantly review our work against our strategic objectives, actively seek views from our stakeholders and assess the environment in which we operate so that we can continuously improve. Therefore, the list of key responsibilities may adapt and change over time within the spirit and nature of organisational change and the development of the role. What we re looking for You ll thrive in a customer-focused, regulatory environment and be passionate about supporting MPs, their staff and trust in democracy through seamless service. You ll be confident helping our customers navigate a principles-based approach to funding decisions, simplifying the complex and using data and insight to inform your conversations. You ll be curious and proactive, knowing when to challenge, when to guide and when to escalate. You ll be comfortable working independently while staying connected to others, including our customers, playing your part in IPSA s success. You will communicate confidently and focus IPSA and our customers on doing the right thing, not the easy thing. You ll be flexible in meeting the needs of our customers and colleagues, owning your work and contributing to agreed projects, developing your skills in a supportive, vibrant, values-led culture and helping shape how we support Parliament now and in the future. You ll help safeguard public money thorough robust governance and reflect IPSA s values in everything you do. The experience and technical level required for the role, along with personal qualities, skills, attributes, and qualifications (where relevant) are listed below. Essential Proven experience in complex customer-facing environments, focusing on building trusting relationships and regulating through seamless service. Strong interpersonal skills to engage confidently and constructively with MPs and their staff, managing complexity and difficult conversations with sensitivity and compassion. Excellent coaching and influencing skills to ensure MPs and their staff make principles-based decisions. Strong analytical and problem-solving skills, with good financial literacy and attention to detail, using data and insight to improve performance and identify trends. A sound moral compass and a commitment to doing the right thing rather than the easy thing. A collaborative approach, contributing to a matrix structure and supporting each other to get the best outcomes for all. A commitment to IPSA s values core values of Staying Connected, Seeing the Bigger Picture, Being Open, Doing the Right Thing and Making a Difference through all that you do. Salary progression We operate a training and competency framework which consists of three stages - learning, developing, qualified. At each stage, there is a set of criteria comprising the relevant knowledge, experience and behaviours that need to be achieved before progressing to the next stage of the framework and each of the stages are linked to pay progression. While the pace at which you may progress is specific to you, it is likely to take between 6 12 months to move through the learning and developing stages before being signed off as qualified. This framework provides colleagues a clear set of expectations to develop competence and confidence. Learning is the introduction to the team, processes and broader knowledge underpinning the role. Developing is about consolidating knowledge and putting it into practice. You can then progress to the final stage as Qualified , at this stage, you will have demonstrated the necessary skills, knowledge and experience to work independently and consistently deliver high quality work. Our commitment and values We re committed to creating an inclusive, vibrant community and to making IPSA a brilliant place to be. At the heart of our people philosophy is our promise to engage, enable, and empower every team member to deliver excellence, learn, and develop every day. Ensuring equality of opportunity is central to this. With diversity of backgrounds, experiences, and thinking IPSA will continue to operate as a high-performing organisation with a truly diverse and inclusive culture. That s why we encourage applications from all backgrounds and communities, such as returning parents or carers who are returning from a career break, people who are LGBTQIA+, from Black, Asian, and other ethnic backgrounds, with a disability, impairment, learning differences or long-term condition, with caring responsibilities, from different geographic regions and people from all socio-economic backgrounds, and any other under-represented groups in our workforce. As well as our Inclusion Panel we have several workplace networks that promote and celebrate diversity, equity, inclusion, and sustainability. Our values guide us and we demonstrate them in all our work. These are Staying Connected, Seeing the Bigger Picture, Being Open, and Doing the Right Thing. and Making a Difference. As a values-based organisation, you can expect them throughout the recruitment process and beyond. Closing date: 5th July 2026 Read Less

Commercial Business Partner SALARY: £70,000 per annum + Benefits

LOCATION: Hybrid - United Kingdom ( London Northern Ireland Scotland Wales England)

JOB TYPE: Full-Time, Permanent
Job Description Overview and context The Commercial team is an enabler for IPSA, offering vital support to internal and external stakeholders to ensure MPs have the goods and services they need for their parliamentary work. The team is responsible for overseeing end to end procurement, operating within a hybrid commercial delivery model in which lower value, routine procurement activity is led by business areas while the Commercial team partner on higher value, more complex activity. As part of its five-year strategy, IPSA has an ambitious plan to offer the UK s 650 MPs access to centralised goods and services to reduce the administrative load, simplify purchasing and improve value for money and sustainability. Reporting to the Head of Commercial, the Commercial Business Partner provides commercial and procurement support through a business partnering model aligned to IPSA s purpose of supporting democracy with great service, fair rule and wise spending. The role builds strong relationships across IPSA to deliver compliant procurement, effective contract management, and practical commercial advice that supports organisational priorities. The role is responsible for ensuring procurement and contract management activity is compliant with relevant legislation, policies and controls. The Commercial team sits within the Finance and Commercial function and works across the organisation and with external stakeholders. Key responsibilities Building strong relationships with the business, engaging with key stakeholders and understanding budgets, pipeline planning, and commercial risks to ensure effective and compliant procurement performance across the end-to-end commercial lifecycle. Providing advice on all stages of procurement and completing administrative processes, from inception to contract management, ensuring procurement activity is compliant with legislation and policy and achieves its intended outcomes. Supporting procurement capability across IPSA through knowledge sharing and delivery of procurement training, while driving best practice and compliance. Working within IPSA s supplier management framework, supporting IPSA to realise benefits and value for money in commercial-related projects. Helping to manage IPSA s spend against strategic contracts, managing issues within the wider IPSA supplier base, including contract renegotiation, strategic issue resolution, and dispute or contract exit. Preparing and reporting timely and accurate contract and procurement information that assesses commercial performance. Undertaking autonomous projects and other ad-hoc pieces of work as well as contributing to wider IPSA projects, as required. Living IPSA s values - staying connected, seeing the bigger picture, being open, doing the right thing and making a difference through all that you do. IPSA is a learning organisation. We constantly review our work against our strategic objectives, actively seek views from our stakeholders and assess the environment in which we operate so that we can continuously improve. Therefore, the list of key responsibilities may adapt and change over time within the spirit and nature of organisational change and the development of the role. What we re looking for You ll be an accomplished commercial professional, qualified at CIPS Level 5 or equivalent membership body (or through significant experience), with demonstrable knowledge of public sector procurement practices, procurement legislation, regulations and principles to keep IPSA safe. You ll care deeply about supporting democracy and delivering value for money for the taxpayer. You ll bring clarity, credibility and calm to commercial activity, working collaboratively in a complex, high-profile environment to help deliver IPSA s strategy, positively influencing how our stakeholders feel about us. You ll bring strong judgement, resilience, and curiosity and you ll be comfortable challenging assumptions to help IPSA navigate opportunities and tough decisions. With deep expertise in commercial and procurement, you ll deliver value for money and strengthen commercial capability across the organisation. You ll have an uncompromising approach to IPSA s procurement and contract management processes, working confidently across IPSA, stakeholders and with suppliers to deliver fit for purpose and best practice solutions. You ll align with IPSA s culture and be flexible and innovative in your approach to work. The experience and technical level required for the role, along with personal qualities, skills, attributes, and qualifications (where relevant) are listed below: Essential CIPS or equivalent qualification: (Level 5+) or significant demonstrable experience. Relationship building and business partnering skills: proven ability to build strong, collaborative relationships with a range of stakeholders, providing sound guidance, and influencing strong outcomes. Commercial lifecycle experience and knowledge: demonstrable experience in procurement of multi-category services, including contract processes, with practical knowledge of the UK s regulatory environment. Public sector procurement: demonstrable experience of public sector procurement regulations and contract management, and up-to-date professional development on the Procurement Act 2023. Commercial capability: excellent commercial acumen, strong judgement and decision making and negotiation skills, with the ability to apply contract management principles to drive best practice and value for money. Excellent data and analysis skills: to provide insight, influence decisions, manage supplier performance and realise benefits. Motivated to deliver results and show resilience: outcomes oriented and able to manage multiple workstreams/projects, working across diverse teams, balancing competing demands and priorities. Communication, engagement and influencing skills: excellent written and verbal communication, aligned to IPSA s brand and tone, with the ability to build collaborative relationships at all levels. Adaptable to change: possesses a flexible and positive attitude to work, change and continuous improvement. Desirable Excellent IT skills including use of Microsoft Office, e-Tendering tools, and Purchase to Pay (ERP) systems. Our commitment and values We re committed to creating an inclusive, vibrant community and to making IPSA a brilliant place to be. At the heart of our people philosophy is our promise to engage, enable, and empower every team member to deliver excellence, learn, and develop every day. Ensuring equality of opportunity is central to this. With diversity of backgrounds, experiences, and thinking IPSA will continue to operate as a high-performing organisation with a truly diverse and inclusive culture. That s why we encourage applications from all backgrounds and communities, such as returning parents or carers who are returning from a career break, people who are LGBTQIA+, from Black, Asian, and other ethnic backgrounds, with a disability, impairment, learning differences or long-term condition, with caring responsibilities, from different geographic regions and people from all socio-economic backgrounds, and any other under-represented groups in our workforce. As well as our Inclusion Panel we have several workplace networks that promote and celebrate diversity, equity, inclusion, and sustainability. Our values guide us and we demonstrate them in all our work. These are Staying Connected, Seeing the Bigger Picture, Being Open, and Doing the Right Thing. and Making a Difference. As a values-based organisation, you can expect them throughout the recruitment process and beyond. Read Less

Careers at SMT GB - Opportunities in Birmingham Location: Birmingham & surrounding areas
Contract: Full-time, Permanent opportunities available About SMT GB SMT GB is the exclusive distributor for Volvo Construction Equipment, Sandvik Mobile Crushing & Screening, and Volvo Penta industrial engines in Great Britain. We are a market leader in our industry, supporting customers across construction, infrastructure, waste, and quarrying sectors. Due to continued growth, we are expanding our teams across our Birmingham region and are keen to hear from individuals interested in building a career with us. About the Opportunities We are recruiting across a range of departments and welcome applications from candidates with varying levels of experience. Opportunities may include: Field Service Engineers (mobile and depot-based roles) Workshop Engineers and Technicians Parts, Service, and Customer Support roles Administration and Business Support positions Engineering and Technical specialists Roles are available both in our depot environment and in field-based positions covering the surrounding region, depending on the opportunity. About You We are looking for individuals who are motivated, reliable, and committed to delivering high-quality work and service. The ideal candidate will bring: Relevant experience within engineering, mechanical, customer service, or business support (depending on role) A strong work ethic and a proactive approach to problem-solving Excellent communication and teamwork skills A commitment to health and safety and quality standards Flexibility and willingness to learn and develop For engineering roles, a recognised qualification or proven experience in plant, construction, or similar machinery is advantageous. What We Offer We provide a supportive working environment and a comprehensive benefits package, including: Competitive salary (dependent on role and experience) Company vehicle (for applicable field-based roles) Pension scheme and life assurance Ongoing training and development opportunities Access to manufacturer training and career progression pathways Employee wellbeing support How to Apply To view our current vacancies and apply, please visit our careers site: If you don't see a role that matches your experience, we still encourage you to apply or register your interest for future opportunities. Not based in Birmingham? No problem. We have opportunities available across our depots nationwide, including: Duxford (Head Office) Birmingham Warrington Horsham Immingham Bruntingthorpe Stirling You can also apply for this role by clicking the Apply Button. Read Less

Herdsperson Required - North Devon An exciting opportunity has arisen for an enthusiastic and motivated Herdsperson to join our progressive 400-cow family run dairy farm in North Devon. We are proud to have been recognised as Devon Dairy Farmers of the Year 2019 and are committed to maintaining high standards of herd health, welfare, and productivity. The Herd & Farm 400-cow autumn block-calving crossbred herd Average yield of 8700litres per cow Milked twice a day through a modern 20/40 DeLaval parlour ACR's, ADF and Auto ID systems Two people in the parlour at all times for efficiency and stock care Paddock grazed by day during the summer months Focus on excellent cow health, fertility, and milk quality Supportive working environment with modern facilities The Role The successful candidate will take a leading role in the day-to-day management of the dairy herd. You will work alongside another team member in the parlour at all times, ensuring smooth operations and high standards of animal care. Essential Skills Proven dairy farming experience DIY AI qualification and practical insemination experience Competent foot trimming skills Strong stockmanship and attention to detail Ability to work alone and as part of a team Able to identify and manage herd health issues Good record keeping Full UK driving licence What we Offer Competitive salary based on experience On farm modern 3 bedroomed house No electric or water bills Regular time off, ensuring a healthy work life balance Opportunity to work within an award-winning dairy business Supportive and progressive farming environment Long Term career prospects for the right candidate If you are passionate about dairy farming, take pride in high standards of stockmanship and are looking for a rewarding role in a successful dairy business we would love to hear from you. To apply please email your CV and covering letter to You can also apply for this role by clicking the Apply Button. Read Less

Excellent development opportunity as a Trainee Trader, well suited to agricultural graduates or early stage careers. As a Trainee Trader, you will be supporting purchasing, pricing, and sales activity across our full fertiliser product range. Taking ownership of customer orders and enquiries, collaborating closely with colleagues, suppliers and customers. You will gain full end-to-end production insight supporting your development of product knowledge and market insight to be able to contribute effectively to the team's success. Support will be given in working towards a FACTS qualification, enabling expertise in nutrient management. Over time, this will equip you to provide informed recommendations and technical advice to our customers, supporting your progression into a more autonomous trading role and the next stage of your career. Main Duties Purchasing - Working with the Senior Trader to secure materials and supporting our production plans at Ultimate Fertilizers. Develop effective relationships with manufactures and wholesalers, shipping agencies - working always to strengthen your industry links and knowledge of the fertilizer business. Sales Activity - Manage customer sales enquiries, phone calls and emails, supporting the trading desk. Take ownership of our Key Account data, ensuring customer information is up to date and maintained on our CRM system, Work with the team to develop sales campaigns. Commercial and Pricing - work with the Senior Trader and the wider team to set, review and agree pricing strategies which will include setting haulage rates. Adopt pricing methods to achieve best margins and so that we are working towards achieving and exceeding our budgetary objectives. About You: Preferably you will hold an agricultural degree or have completed your agricultural college studies in a relevant discipline with some hands-on work experience within the sector and able to translate your knowledge into practical application. Genuine interest in developing and growing your skills and knowledge base. Willing to work towards gaining your FACTS qualification. Over time, this will enable you to confidently provide informed advice and recommendations to our customers as a trusted advisor. Teamwork is central to our culture, we are looking for someone who thrives in a collaborative environment and brings a positive can-do attitude to working with others. Full and clean UK Drivers License Read Less