• Director, Medical Safety Scientist  

    - Greater London
    If you are a current Jazz employee please apply via the Internal Caree... Read More
    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
  • Director, Medical Safety Scientist  

    - Cambridgeshire
    If you are a current Jazz employee please apply via the Internal Caree... Read More
    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
  • Medical Director, Medical Safety  

    - Cambridgeshire
    If you are a current Jazz employee please apply via the Internal Caree... Read More
    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
  • Medical Director, Medical Safety  

    - Greater London
    If you are a current Jazz employee please apply via the Internal Caree... Read More
    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
  • Associate Medical Director, Medical Safety  

    - Greater London
    If you are a current Jazz employee please apply via the Internal Caree... Read More
    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
  • Associate Medical Director, Medical Safety  

    - Cambridgeshire
    If you are a current Jazz employee please apply via the Internal Caree... Read More
    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 Caree... Read More
    If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Batch Processing Record Reviewer is responsible for ensuring all batches processed in B750 Extraction Facility have Batch Manufacturing Records completed in compliance with requirements. This requires all processing steps to have been completed and documented with respect to ALCOA+ principles and all Critical Process Parameters (CPPs) having been met prior to approving the manufacturing review. Any deficiencies must be documented and where appropriate deviations raised and referenced. The Job Holder must ensure compliance with Health and Safety (H Read Less
  • If you are a current Jazz employee please apply via the Internal Caree... Read More
    If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description: To assist the Quality Compliance Manager and other QA team members in the implementation of the Quality Systems at the KSP facility and associated contractor sites. Essential Functions Key Responsibilities / Accountabilities Managing and maintaining of the quality management system: Corrective and preventative actions (CAPA) Deviations Change control Supplier and customer complaints Quality risk management (QRM) Leading root cause analysis (RCA) Liaising with global process owners to ensure consistency in the QMS between sites and functions Training in the QMS Collating QMS metrics and KPI data Presenting QMS data at quality management review (QMR) meetings Quality Vendor Management New Supplier/Vendor onboarding Internal and External Audit management Detailed Responsibilities / Accountabilities Prepares, reviews, updates and completes QMS processes Ensures training records are kept up to date Carries out their work in a way that will not adversely affect their own, or others’ health, safety and security or the environment and reports any shortcomings in GW arrangements Ensure all complaints are documented, investigated and closed out within agreed guidelines. That issues are escalated as required Strives to ensure quality events are closed within agreed timeframes and facilitates management of quality events across KSP Assisting in the assembly of the product quality review Ensuring that regulatory, marketing partners due diligence and other audit/inspections performed at GW are supported with efficient document retrieval and supply of the technical information Management of quality qualifications and approval of vendor to ensure compliance to regulations. Ensures vendors are maintained and monitored using a risk-based approach which links into the external auditing process and the business. Lead and support internal and external audits, report write up and response management. Assist in the creation of technical agreements, supplier agreements and quality risk assessments Participate or leads projects to deliver improvements in productivity and efficiency in all areas relevant to complaints Authors and reviews all required quality documents Creates training packages for QMS process at KSP Authors and edits SOPs associated with the QMS at KSP Required Knowledge, Skills, and Abilities Skills: Working knowledge of office IT packages High level of written and verbal communication skills Attributes and Behaviors: Motivated individuals that have extensive experience across many disciplines within the pharmaceutical industry and have spent a significant period of time within quality assurance, demonstrating the ability to develop quality systems. Required / Preferred Education and Licenses Education: Typically, Bachelor’s degree (or equivalent) in science or related discipline Post-graduate qualifications (Master’s, PhD) preferred Experience: Extensive work experience in the Pharmaceutical, Biotechnology or a related industry Experience working within a quality environment, including experience in GMP, GACP and GDP #LI-SP1 #LI-onsite Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less
  • If you are a current Jazz employee please apply via the Internal Caree... Read More
    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 Caree... Read More
    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 Caree... Read More
    If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Biologics Drug Substance Senior Quality Assurance Specialist is Responsible for performing key Quality tasks in respect of Company Biologics products. Work in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations, as well as Internal Quality Systems. Reporting directly to the Drug Substance Lead, External Manufacturing QA. Essential Functions/Responsibilities The position is responsible for monitoring and supporting the quality performance of contract manufacturing organisations and material suppliers to all applicable GXP standards. Responsible for, but not limited to: Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product related investigations. CMO Batch file and product testing record review and approval. Associated lot Disposition activity. Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations Collaboration with all contract manufacturers, packagers and testing laboratories to resolve any quality issues. Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, as required. Highlighting any risks associated with maintaining supply of commercial drug products to all markets. Conducting vendor audits and vendor site visits as required. Assisting in internal audits and regulatory agency inspections. Summarizing CMO Annual Product Quality Reviews and supporting regulatory submissions Assist with the generation of Jazz APQR (Annual Product Quality Review). Maintaining product related Quality Technical Agreements (QTAs). Understanding new regulations and guidelines, as they apply to the company business and implement systems and procedures to incorporate these new regulations as appropriate. Review and approve moderate complexity deviations and associated corrective actions. Support the generation of new, as well as improvement of, existing department SOPs. Support delivery of projects. Work with management to resolve project issues and resource constraints within the team. Liaise with the internal and external stakeholders to resolve and clarify any point of issue. Review and approve less complex validation documents. Partner with other departments/groups to problem-solve and address moderately complex issues. Collaborate in the continuous improvement of the QA processes, identifying opportunities and leading them up to the implementation. Represent QA in cross-functional project teams for moderately difficult projects. Participate in and facilitate regulatory inspection readiness. Coordinates and collaborates with other teams to meet organizational goals and work requirements. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; solves moderately complex problems and can identify viable and often innovative options. Uses analytical skills and judgment to recommend the "best" solution. Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations. Maintain quality from cell banking through to production and post-release events (e.g., stability, product complaints). Required Knowledge, Skills, and Abilities Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry. Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, deep knowledge of Biologics manufacturing. Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site. Experience with contract manufacturing is desirable. Significant experience (>5years) of commercial and/or late state clinical phase GMP manufacturing of biologics. Highly organised, with exceptional time management and prioritization. Excellent verbal and written communication skills. Experience in Drug Product Manufacture in addition to Drug Substance an advantage QP eligibility or progress toward QP certification is highly desirable. Required/Preferred Education and Licenses Bachelor’s degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology or a related discipline Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html . Read Less
  • Principal, AI Data Science  

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

    - Oxfordshire
    -
    Research Assistant SALARY: from £30,000 per annum (depending on skills... Read More
    Research Assistant SALARY: from £30,000 per annum (depending on skills and experience) JOB TYPE: 12 Months, Full-Time, Fixed-Term Contact (Maternity Cover) The Rosalind Franklin Institute (the Franklin) is a technology institute established by the UK Government as a unique centre committed to advancing tools that are needed to transform healthcare in the future. The Institute brings together researchers in life and physical sciences, and engineering, to develop a spectrum of tools which we will use to image, interpret and intervene in biological systems. These insights will speed up the discovery of new medicines, help find new diagnostics and contribute to a deeper understanding of human health and disease. Our Science Strategy seeks to focus the Franklin s research and unite our researchers around our Technology Innovation Challenges and Life Science Challenges. We are currently seeking a highly motivated Research Assistant to join our Nanobody Discovery team at the Franklin to develop and expand the use of nanobodies as molecular probes for structural and cell biology applications. The successful candidate will contribute to projects that further develop our nanobody technology platform as well as introducing new technologies. Key Responsibilities Research Assistant As a Research Assistant you will: Screen nanobody expression libraries by phage display to isolate specific binding proteins. Express, purify and characterise antigen binding of selected nanobodies. Take responsibility for management of samples and data entry into the nanobody database. Present and interpret results at internal lab meetings. Take responsibility with others to ensure that work in the laboratory is conducted safely and in accordance with local health and safety policies. Participate in and support public engagement by the Franklin. This job description sets out the skills and experience we believe are needed to be able to do this job but, research also tells us women are much more likely than men to take this list of requirements as absolute and self-select out of the process. If you think you can deliver this role then we want to hear from you, regardless of the boxes you did not tick. In return we offer: 25 days holidays plus bank holidays and Christmas holiday shutdown Generous pension scheme (employer s contribution currently up to 18%) Group Life Assurance (also known as Group Life Insurance or Death in Service) Buying and Selling Annual Leave Workplace Nursery Salary Sacrifice Scheme Hub building with state-of-the-art laboratories Hybrid and flexible working Training and development opportunities for staff at all levels Bus pass discount scheme and good transport links to Oxford and surrounding areas Cycle to Work Scheme Access to employee discount platform (Perkbox) Occupational Health and wellbeing support including Employee Assistance (24/7 support and counselling) Health Cash Plan Subsidised canteen and food outlets on campus Free on-site parking Campus location in beautiful countryside with social and sports clubs open to staff The Franklin s underlying aim is to produce the best science for research today, and this means resolutely embracing a diverse team, who have a wide range of experiences, skills and knowledge to push forward on the innovative work our institution delivers. Both our work and our institution are better for it. We are committed to creating an inclusive environment where every applicant has an equal opportunity to showcase their talents and abilities. This includes making adjustments for candidates with specific needs. Please contact us to discuss your requirements confidentially. At the Rosalind Franklin Institute we also welcome applications from all around the world! Read Less
  • Finance Director - Manufacturing Location: Onsite - Liverpool, United... Read More
    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
  • Software Engineer Python React Golang AWS  

    - London
    -
    Software Engineer / Full Stack Developer (Python React Golang AWS) Lo... Read More
    Software Engineer / Full Stack Developer (Python React Golang AWS) London to £90k Are you a full stack technologist who enjoys working on Greenfield apps? You could be progressing your career as a Software Engineer at a tech scale-up that are enjoying great success with their AI workforce optimisation software that connects flexible temporary workers (e.g. students) with clients in the hospitality industry, enabling clients to maximise staff in busy times through AI scheduling. What's in it for you: Salary to £90k Stock options Private medical care Gym and dog friendly office Influential role that you can shape as the company grows Your role: As a Software Engineer you'll design and develop new features and enhancements as the company scales from 250,000 users through to millions and transitions from a monolith to microservices architecture. You'll work across the full software development lifecycle, taking ownership of Greenfield projects, working with a range of technology from Python and Go on the backend through to Django and Flutter on the frontend within an AWS cloud environment. Location / WFH: You'll join colleagues in the North London office 3-4 days a week where you can enjoy a range of perks including paid for gym and dog friendly office (as well as great bars and restaurants for after work!). About you: You have Full Stack development experience, having worked with Python and Go / Golang, as well as Django, Flutter, or React, databases (PostgreSQL) and AWS You have a strong understanding of distributed systems and event-driven architectures You enjoy working on Greenfield projects in fast paced environments, ideally you will have start-up or scale-up experience You're collaborative, curious and keen to learn new technologies - comfortable working with AI tools such as Claude You are degree educated in Computer Science or similar technical discipline, having achieved a 2.1 or above from a top tier university Apply now to find out more about this Software Engineer / Full Stack Developer (Python React Golang AWS) opportunity. Read Less
  • Full Stack Engineer C# .Net Core JavaScript  

    - Hertfordshire
    -
    Full Stack Engineer / Developer (C# .Net Core JavaScript AWS) St Alba... Read More
    Full Stack Engineer / Developer (C# .Net Core JavaScript AWS) St Albans / WFH to £100k Opportunity to progress your career in a hands-on role at a technology driven trading company that invest in Sports betting markets, with a flat structure where you will get your voice heard and can make a real impact on the bottom line, earning significant bonuses. What's in it for you: As a Full Stack Engineer / Developer you will earn a competitive package: Salary to £100k Bonus 25 days holiday, rising to 30 after 2 years Enhanced parental leave Contributory pension scheme Private Medical MSDN subscription Discounts for gym membership, travel and cinema Sabbatical after 10 years of service Flexible working with 2 days work from home per week in a hybrid model Your role: As a Full Stack Engineer you'll join an Agile development team to design and develop new features and enhancements to complex Payments and client systems within a microservices environment (300 services). You'll be working with a modern tech stack using C# .Net Core, AWS, Kubernetes, Kafka, Redis and TypeScript / Angular; using the right tool for the job, you'll be able to pick up new technologies and make recommendations for improvements. Location / WFH: You'll join colleagues in St. Albans, Hertfordshire (parking available), 10 minute walk from local station, with the flexibility to work from home twice a week. About you: You have strong C# .Net Core backend development skills You have JavaScript experience, combined with Angular or React You have experience with AWS and microservices You have a thorough understanding of Computer Science fundamentals such as OOP, Design Patterns, Data Structures, Algorithms You enjoy collaborating, learning new things and sharing knowledge You are degree educated in Computer Science or closely related discipline Apply now to find out more about this Full Stack Engineer / Developer (C# .Net Core JavaScript) opportunity. At Client Server we believe in a diverse workplace that allows people to play to their strengths and continually learn. We're an equal opportunities employer whose people come from all walks of life and will never discriminate based on race, colour, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. The clients we work with share our values. Read Less
  • Full Stack Engineer TypeScript Node  

    - London
    -
    Full Stack Engineer / Developer (TypeScript Node) London / WFH to £10... Read More
    Full Stack Engineer / Developer (TypeScript Node) London / WFH to £100k Are you a technologist Full Stack Engineer looking for an opportunity to take ownership and progress your career? You could be joining a scaling FinTech, the core product is a private equities / alternative investment management platform. As a Full Stack Engineer you will design and develop web based and mobile applications, primarily using TypeScript and Node within an Azure cloud environment. You'll take ownership across the full development lifecycle, including testing and deploying into production. You will also contribute to research and evaluation of new AI / Machine Learning algorithms and stay up to date with industry trends and emerging technologies, collaborating to design new features and functionality. Location / WFH: You'll join colleagues in the London office three days a week with flexibility to work from home the other two days. About you: You have a BSc degree in a STEM discipline, from a Russel Group university You have strong technical skills with TypeScript, Node, Nest, React and other web technologies such as HTML and CSS You have experience of integrating APIs and AI services You have a good understanding of Large Language Models (LLMs) and Natural Language Processing using Claude, OpenAI, Gemini, Foundry etc You're collaborative with advanced communication skills Ideally you will have experience within Fintech or Financial Services environments What's in it for you: Salary to £110k + bonus Impactful role with excellent career progression Hybrid working (x3 days in London) Apply now to find out more about this Full Stack Engineer / Developer (TypeScript Node) opportunity. Read Less
  • Product Management Lead B2B SaaS  

    - London
    -
    Product Management Lead (B2B SaaS) London / WFH to £110k Do you have... Read More
    Product Management Lead (B2B SaaS) London / WFH to £110k Do you have expertise with Product Management processes? You could be progressing your career in an impactful role at a market leading FinTech company that provides a highly functional suite of software products to support post-trade processing for clients including most of the financial institutions across the globe, processing around $3 trillion per day in securities lending. As the Product Management Lead you will be the operational backbone of the Product team. This role is a force multiplier: you will own and enforce the Product Delivery Lifecycle (PDLC), build the metrics layer that drives accountability and predictability and spearhead AI adoption across product workflows, enabling every Product Manager to operate at a higher standard, faster. Location / WFH: You'll join colleagues in the City based office, with flexibility to work from home twice a week. About you: You have a Product Manager background and strong experience in Product Operations with a track record of improving delivery predictability and quality through effective product processes You have experience within a B2B SaaS environment You have hands-on experience with frameworks such as WSJF, RICE or similar You have strong analytical skills, with experience of defining KPIs, building dashboards and using delivery metrics to drive continuous improvement You have a good knowledge of Agile methodologies including backlog management, Sprint planning and iterative delivery You have experience of using AI tools such as GitHub Copilot, ChatGPT or Claude to improve processes and workflows You have advanced communication and stakeholder management skills What's in it for you: As a Product Management Lead (B2B SaaS) you will earn a competitive package: Salary to £110k Bonus 25 days holiday 5% pension contribution Life Assurance Private Medical Insurance, Eyecare Employee Assistance Programme (including 24/7 GP, mental health support, financial and legal advice) Cycle to Work scheme Apply now to find out more about this Product Management Lead (B2B SaaS) opportunity. At Client Server we believe in a diverse workplace that allows people to play to their strengths and continually learn. We're an equal opportunities employer whose people come from all walks of life and will never discriminate based on race, colour, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. The clients we work with share our values. Read Less
  • C# Software Engineer .Net SQL React  

    - London
    -
    C# Software Engineer / Full Stack Developer (C# .Net SQL React) Londo... Read More
    C# Software Engineer / Full Stack Developer (C# .Net SQL React) London / WFH to £80k Do you have experience across the full tech stack within a finance environment? You could be progressing your career at a boutique Asset Manager that specialise in Fixed Income markets and have multi-billion dollars under management. As a C# Software Engineer you'll assist with ongoing efforts to optimise the business through the use of automation and AI. You'll have exposure across the full technology stack based on Azure, C#, SQL, ASP.Net and React. Typically, you'll be working on developing and maintaining data feeds, application development and the web GUI. There's a collaborative environment where you'll be supported with continual learning and self development opportunities. Location / WFH: You'll join the team in the London, City office Tuesdays, Wednesdays and Thursdays with flexibility to work from home on Mondays and Fridays. About you: You have strong C# .Net backend development skills You have strong SQL skills and good understanding of databases You have experience with React for front end / GUI development You have a good understanding of financial markets and the trade lifecycle You have a genuine enthusiasm for technology, likely to have your own GitHub / personal projects and keep up to date with the latest innovations in AI You have strong analysis and problem solving skills You're collaborative with great communication skills You have achieved a 2.1 or above in a STEM discipline What's in it for you: Salary to £80k Pluralsight subscription Hybrid working Career progression Apply now to find out more about this C# Software Engineer / Full Stack Developer (C# .Net SQL React) opportunity. At Client Server we believe in a diverse workplace that allows people to play to their strengths and continually learn. We're an equal opportunities employer whose people come from all walks of life and will never discriminate based on race, colour, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. The clients we work with share our values. Read Less
  • Data Engineer Python - FinTech  

    - London
    -
    Data Engineer (Python LLM API) London / WFH to £100k Are you a high... Read More
    Data Engineer (Python LLM API) London / WFH to £100k Are you a highly technical Data Engineer with FinTech / finance experience looking for an opportunity to progress your career? You could be joining a scaling FinTech, the core product is a private equities / alternative investment management platform. As a Data Engineer you will focus on building scalable data pipelines; improving, creating and maintaining data ingest pipelines for receiving data from Fund admins. You'll be working primarily with Python, Typescript and APIs within an Azure cloud environment. You'll collaborate with the wider engineering team, acting as a champion for good data and good data architecture and stay up to date with emerging technologies and best practices. Location / WFH: You'll join colleagues in the London office three days a week with flexibility to work from home the other two days. About you: You have a BSc degree in a STEM discipline, from a Russel Group university You have strong commercial data engineering experience, building scalable data pipelines You have strong Python coding ability, ideally you will also have experience with TypeScript (or be happy to learn it) You have a good understanding of APIs You've used LLMs to create business value You have experience within cloud environments, Azure preferred You're collaborative with advanced communication skills What's in it for you: Salary to £100k + bonus Impactful role with excellent career progression Hybrid working (x3 days in London) Apply now to find out more about this Data Engineer (Python LLM API) opportunity. Read Less
  • Network Engineer  

    - Lancashire
    -
    Network Engineer (CCNA / CCNP Palo Alto) Leyland / WFH to £60k Are y... Read More
    Network Engineer (CCNA / CCNP Palo Alto) Leyland / WFH to £60k Are you a technologist Network Engineer? You could be progressing your career in a senior, hands-on Network Engineer role at a global travel brand. As a Network Engineer you will provide 3 rd line support and administration for LAN, WAN and remote networks; designing, implementing and maintaining network solutions across the organisations infrastructure. You'll have a mixture of BAU and project based work, including monitoring and analysing network availability, reliability, maintainability and serviceability. You will troubleshoot and resolve complex issues affecting business critical enterprise and carrier-grade networks and also recommend and deliver cost-effective, end-to-end network designs aligned with business requirements. Location / WFH: You'll join colleagues in the Leyland office with free onsite gym and restaurant with flexibility to work from home two days a week. About you: You have advanced network troubleshooting and diagnostics experience You have enterprise networking architecture and design skills You have a deep knowledge of LAN / WAN and Wi-Fi technologies You have strong experience with Network performance and availability management You have a good knowledge of cost optimisation and solution design You have a CCNA or CCNP certification, bonus points for CCIE They are using Palo Alto but experience with Cisco or Juniper networking / firewalls is fine What's in it for you: Salary to £60k Pension, Life Assurance, Family Private Medical Care 25 days holiday, plus ability to buy and sell 5 days a year Employee Assistance Programme Travel discounts on package holidays Charity volunteer days Social and industry events Various other perks such as Cycle to Work scheme, Taste Card membership, free eye tests Apply now to find out more about this Network Engineer (CCNA CCNP Palo Alto) opportunity. At Client Server we believe in a diverse workplace that allows people to play to their strengths and continually learn. We're an equal opportunities employer whose people come from all walks of life and will never discriminate based on race, colour, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. The clients we work with share our values. Read Less
  • Backend Software Engineer Python FastAPI SQL  

    - London
    -
    Backend Software Engineer / Developer (Python FastAPI SQL Databricks)... Read More
    Backend Software Engineer / Developer (Python FastAPI SQL Databricks) London to £95k Are you a data centric Backend Software Engineer with strong Python, SQL and FastAPI skills? You could be progressing your career in a senior, hands-on role at a fast growing, global Insurance Underwriting technology provider that focusses on developing a complex SaaS calculation platform for rapidly growing Cyber Security insurance markets. As a Backend Software Engineer you will design and develop data centric backend services for the core platform with a focus on Python coding and building FastAPIs within an Azure environment with Databricks. You'll participate in the design and implementation of advanced mechanisms for data ingestion, transformation, mass parallel orchestration of network IO and will model data for a variety of purposes. You'll also collaborate with the Infrastructure Team to maintain Infrastructure as Code and develop new features on the engineering platform. Location / WFH: There's a hybrid work from home model with three days a week in the high spec London, City office with rooftop bar. About you: You have strong Python backend software engineering skills You have experience of building FastAPIs You have a good knowledge of public cloud services, they're using Azure but experience with AWS or GCP is fine You have experience of working with data at scale You have strong SQL skills (PostgreSQL, SQL Server - Azure Databricks experience highly preferred) You have a thorough knowledge of Computer Science fundamentals including Data Structures, Design Patterns, OOP You're collaborative and pragmatic with great communication skills What's in it for you: Salary to £95k + bonus 25 days holiday Private Medical Insurance (including dental and optical cashback) Life Insurance, Income Protection Pension Subsidised gym membership X4 paid volunteering days per year Season ticket loan Employee Assistance Programme Impactful role with great career progression Apply now to find out more about this Backend Software Engineer / Developer (Python FastAPI Databricks Azure) opportunity. At Client Server we believe in a diverse workplace that allows people to play to their strengths and continually learn. We're an equal opportunities employer whose people come from all walks of life and will never discriminate based on race, colour, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. The clients we work with share our values. Read Less
  • Market Operations Analyst - Trade Reconciliation  

    - Newcastle Upon Tyne
    -
    Market Operations Analyst (Trade Reconciliation) Newcastle to £55k D... Read More
    Market Operations Analyst (Trade Reconciliation) Newcastle to £55k Do you have a first class education combined with buy-side / sell-side operations experience? You could be progressing your career at a scaling Technology Consultancy within the finance division. As a Market Operations Analyst you will design, prioritise, build and perform daily controls through a suite of reconciliations (position, trade, cash) across Equities, Fixed Income, Rates, Futures, Credit and Commodities asset classes. You'll provide extensive core operational support and input to the continued build-out of infrastructure across the business, working with both technology and external vendors to build out efficient and scalable processes across both new and existing product verticals Location: You'll join colleagues in brand new Central Newcastle offices on a full-time basis (Monday to Friday), working hours with some flexibility. The offices are well equipped and offer fantastic views across the City and the local countryside, many employees walk or cycle in (onsite showers available!), there's a diverse, social team atmosphere with many employees having recently relocated and lots of support available. About you: You have an outstanding record of academic achievement - 1.1, first class degree in Mathematics, Finance, Economics (or closely related discipline) from a top tier university (i.e. Russel Group or top 100 global university), backed by A grades at A-level You have trade reconciliation experience, any asset class is fine You are naturally curious, enjoy problem solving and have advanced analytical skills You have a keen interest in financial markets and are motivated to learn more and progress your career in this area You have excellent written and verbal communication and collaboration skills What's in it for you: As a Market Operations Analyst you will earn a competitive package: Salary to £55k Bonus 25 days holiday Bupa healthcare Generous pension contribution Continuous learning and career development opportunities Social team atmosphere with a range of events and early finish for drinks on Fridays Apply now to find out more about this Market Operations Analyst opportunity. At Client Server we believe in a diverse workplace that allows people to play to their strengths and continually learn. We're an equal opportunities employer whose people come from all walks of life and will never discriminate based on race, colour, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. The clients we work with share our values. Read Less
  • Senior Product Designer  

    - Cambridgeshire
    -
    Senior Product Designer Cambridge / WFH to £60k Opportunity to progr... Read More
    Senior Product Designer Cambridge / WFH to £60k Opportunity to progress your career working on real-world problems within a highly successful SaaS tech company that provides AI and ML products for automotive innovators to design better cars faster and achieve greater sustainability through Machine Learning. As a Senior Product Designer you'll lead the design process end-to-end, from discovery and user research through to delivery and launch, translating insights into clear product decisions and user-focused experiences. You'll take ownership of the written UX layer, including UI copy, content guidelines and user documentation, alongside contributing to the evolution of the design system and sophisticated data visualisation experiences. You'll work closely with product managers, software engineers, ML researchers and domain experts to create intuitive experiences that help users make faster, more confident decisions. Location / WFH: You'll join the team in Cambridge, ideally once a week (potentially once a month) with flexibility to work from home most of the time. About you: You have experience of working end-to-end on complex B2B SaaS products You have strong visual and interaction design skills, proven on data-heavy interfaces You have experience working with data and data visualisation You have experience of running user research studies and translating insights into actions You have strong writing and content design skills (demonstrated in case studies) You're comfortable using AI tools and agentic AI development You're collaborative and pragmatic with great communication skills What's in it for you: Salary to £60k Private Health Care Life Assurance Up to 6% employer pension contribution 25 days holiday Apply now to find out more about this Senior Product Designer opportunity. At Client Server we believe in a diverse workplace that allows people to play to their strengths and continually learn. We're an equal opportunities employer whose people come from all walks of life and will never discriminate based on race, colour, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. The clients we work with share our values. Read Less
  • Product Manager PoS  

    - London
    -
    Product Manager (PoS Payments Hospitality) London / WFH to £90k Wou... Read More
    Product Manager (PoS Payments Hospitality) London / WFH to £90k Would you like to join a scale-up technology company in an influential role where you can take ownership and see the business impact of what you do? You could be progressing your career as a Product Manager, working on complex systems for the core product, a financial operating system for live events which reduces queue times for customers and maximises revenue for vendors. As a Product Manager you'll take ownership of key product roadmap areas, driving prioritisation, backlog management and feature delivery from concept through to release. Working closely with Business Analysts and engineering teams, you'll help scope solutions that balance technical feasibility, customer value and commercial impact. This is a highly collaborative role where you'll partner with architects, Tech Leads, Product, Operations and commercial stakeholders to align priorities and deliver scalable solutions. You'll manage competing demands, communicate roadmap progress clearly and ensure stakeholder expectations are effectively managed throughout the delivery lifecycle. You'll also contribute to wider strategic and leadership discussions, bringing a strong commercial mindset and understanding of operational impact, while balancing immediate customer needs against long-term product direction. Location / WFH: Initially (first 6 months) you'll be expected to join the team in the London office 3-4 days a week so you can get a full understanding of the product and the team, following this there's lots of flexibility including the ability to work abroad for part of the year. About you: You have relevant industry experience i.e. POS platforms, Payments, Event tech, Hospitality tech You have a strong understanding of payments ecosystems, operational workflows, integrations and multi-stakeholder product environments You have strong Product Management experience You have experience of collaborating with technical teams, BAs and business stakeholders You have advanced communication and stakeholder management skills What's in it for you: Salary to £90k Pension Influential role with great career progression as the company scales Potential equity Apply now to find out more about this Product Manager (PoS Payments Hospitality) opportunity. Read Less
  • Python Developer FastAPI SQL Databricks  

    - London
    -
    Python Developer / Backend Software Engineer (FastAPI SQL Databricks)... Read More
    Python Developer / Backend Software Engineer (FastAPI SQL Databricks) London to £95k Are you a data centric Python Developer with strong SQL and FastAPI skills? You could be progressing your career in a senior, hands-on role at a fast growing, global Insurance Underwriting technology provider that focusses on developing a complex SaaS calculation platform for rapidly growing Cyber Security insurance markets. What's in it for you: Salary to £95k + bonus 25 days holiday Private Medical Insurance (including dental and optical cashback) Life Insurance, Income Protection Pension Subsidised gym membership X4 paid volunteering days per year Season ticket loan Employee Assistance Programme Impactful role with great career progression Your role: As a Python Developer you will design and develop data centric backend services for the core platform with a focus on Python coding and building FastAPIs within an Azure environment with Databricks. You'll participate in the design and implementation of advanced mechanisms for data ingestion, transformation, mass parallel orchestration of network IO and will model data for a variety of purposes. You'll also collaborate with the Infrastructure Team to maintain Infrastructure as Code and develop new features on the engineering platform. Location / WFH: There's a hybrid work from home model with three days a week in the high spec London, City office with rooftop bar. About you: You have strong Python backend software engineering skills You have experience of building FastAPIs You have a good knowledge of public cloud services, they're using Azure but experience with AWS or GCP is fine You have experience of working with data at scale You have strong SQL skills (PostgreSQL, SQL Server - Azure Databricks experience highly preferred) You have a thorough knowledge of Computer Science fundamentals including Data Structures, Design Patterns, OOP You're collaborative and pragmatic with great communication skills Apply now to find out more about this Python Developer / Backend Software Engineer (Python FastAPI Databricks Azure) opportunity. At Client Server we believe in a diverse workplace that allows people to play to their strengths and continually learn. We're an equal opportunities employer whose people come from all walks of life and will never discriminate based on race, colour, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. The clients we work with share our values. Read Less
  • Lead AI Engineer Python LLM - Tech Consultancy  

    - London
    -
    Lead AI Engineer (Python LLM MLOps) London / WFH to £125k Are you a... Read More
    Lead AI Engineer (Python LLM MLOps) London / WFH to £125k Are you an experienced Software Engineer with a strong knowledge of AI, LLMs and agentic coding? You could be progressing your career at a global finance technology consultancy, working with clients including global Investment Banks and financial services organisations. What's in it for you: Salary to £125k Pension, Life Assurance, Income Protection Private medical care for you and your family, including mental health Travel Insurance Charitable giving Gym membership for you and your family Flexible holiday scheme Your role: As a Lead AI Engineer you will architect AI solutions, embed them within enterprise environments and drive impactful outcomes through advanced engineering, scalable pipelines and deep cross-functional collaboration. This is a highly technical role where you'll be leading client projects, productionising systems and running multi-modal LLMs, using your expertise to build and deploy cutting-edge generative AI and agentic systems across the financial services sector. About you: You have hands-on experience deploying LLMs and multi-modal models at scale in production You have a strong understanding of scalable MLOps, observability and cloud-native AI deployment You have strong Python coding skills and API development skills You're collaborative and pragmatic with advanced stakeholder communication, problem-solving and project management skills in Agile environments You have achieved a 2.1 or above bachelor's degree in Computer Science, AI or related STEM disciplines Experience with any of the following is advantageous: agentic frameworks (e.g., LangChain, LlamaIndex), deep learning frameworks, Langfuse, Langsmith, MCP (Model Context Protocol), bias mitigation techniques Apply now to find out more about this Lead AI Engineer (Python LLM MLOps) opportunity. Read Less

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