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 for more information. Brief Description: The Manager, Clinical outsourcing will manage the clinical trial outsourcing for Jazz Pharmaceuticals' clinical development programs across clinical study phases pre- and post-authorization. Under the direction of the Associate Director, Clinical Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of Jazz' clinical studies. Essential Functions Assist Associate Director and senior leadership in the management of the outsourcing, vendor selection and clinical contracts process Generate RFIs, RFPs, and contract templates Negotiate and maintain clinical development contracts, including vendor CDAs, MSAs investigator meeting agreements, Statements of Works for external clinical service providers, consultant agreements and specialty vendor contracts Oversee CRO/FSP activities in regard to CDAs, vendor Statements of Work and clinical site agreements Submit purchase requisitions and manage contract approvals through Jazz's S2P system Interface with cross-functional teams, including legal, procurement, compliance and clinical operations functions in selection and management of vendors and study sites Manage selection process and develop strong relationships with vendors in conjunction with cross-functional teams Organize bid defense meetings as required Develop and maintain tracking tools (spreadsheets, databases, etc.), Attend team meetings as appropriate, represent Clinical outsourcing on cross-functional clinical trial working group meetings. Assist in the monthly accrual process and financial reporting for projects Assist Director with departmental process improvements as needed Work in collaboration with Compliance on FMV; May help train individual contributor/professional employees Required Knowledge, Skills, and Abilities Bachelor's degree with three years of clinical outsourcing experience Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization Experience generating RFPs, RFIs, and study budget/contract templates Proven track record negotiating contracts and budgets with both U.S. and international vendors In-depth knowledge of compliance and legal issues related to the conduct of clinical trials phase 1 - 3. Experience with post authorization phase 4 preferred. Experience managing CROs, central laboratories, and other clinical study vendors, including trial sites a plus. Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety Ability to prioritize and handle multiple tasks simultaneously Maintain up to date information on changing healthcare regulations affecting clinical trial payments Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees. Some limited travel may be required 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: .
Dec 11, 2025
Full time
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 for more information. Brief Description: The Manager, Clinical outsourcing will manage the clinical trial outsourcing for Jazz Pharmaceuticals' clinical development programs across clinical study phases pre- and post-authorization. Under the direction of the Associate Director, Clinical Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of Jazz' clinical studies. Essential Functions Assist Associate Director and senior leadership in the management of the outsourcing, vendor selection and clinical contracts process Generate RFIs, RFPs, and contract templates Negotiate and maintain clinical development contracts, including vendor CDAs, MSAs investigator meeting agreements, Statements of Works for external clinical service providers, consultant agreements and specialty vendor contracts Oversee CRO/FSP activities in regard to CDAs, vendor Statements of Work and clinical site agreements Submit purchase requisitions and manage contract approvals through Jazz's S2P system Interface with cross-functional teams, including legal, procurement, compliance and clinical operations functions in selection and management of vendors and study sites Manage selection process and develop strong relationships with vendors in conjunction with cross-functional teams Organize bid defense meetings as required Develop and maintain tracking tools (spreadsheets, databases, etc.), Attend team meetings as appropriate, represent Clinical outsourcing on cross-functional clinical trial working group meetings. Assist in the monthly accrual process and financial reporting for projects Assist Director with departmental process improvements as needed Work in collaboration with Compliance on FMV; May help train individual contributor/professional employees Required Knowledge, Skills, and Abilities Bachelor's degree with three years of clinical outsourcing experience Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization Experience generating RFPs, RFIs, and study budget/contract templates Proven track record negotiating contracts and budgets with both U.S. and international vendors In-depth knowledge of compliance and legal issues related to the conduct of clinical trials phase 1 - 3. Experience with post authorization phase 4 preferred. Experience managing CROs, central laboratories, and other clinical study vendors, including trial sites a plus. Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety Ability to prioritize and handle multiple tasks simultaneously Maintain up to date information on changing healthcare regulations affecting clinical trial payments Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees. Some limited travel may be required 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: .
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 for more information. Brief Description: The Manager, Clinical outsourcing will manage the clinical trial outsourcing for Jazz Pharmaceuticals' clinical development programs across clinical study phases pre- and post-authorization. Under the direction of the Associate Director, Clinical Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of Jazz' clinical studies. Essential Functions Assist Associate Director and senior leadership in the management of the outsourcing, vendor selection and clinical contracts process Generate RFIs, RFPs, and contract templates Negotiate and maintain clinical development contracts, including vendor CDAs, MSAs investigator meeting agreements, Statements of Works for external clinical service providers, consultant agreements and specialty vendor contracts Oversee CRO/FSP activities in regard to CDAs, vendor Statements of Work and clinical site agreements Submit purchase requisitions and manage contract approvals through Jazz's S2P system Interface with cross-functional teams, including legal, procurement, compliance and clinical operations functions in selection and management of vendors and study sites Manage selection process and develop strong relationships with vendors in conjunction with cross-functional teams Organize bid defense meetings as required Develop and maintain tracking tools (spreadsheets, databases, etc.), Attend team meetings as appropriate, represent Clinical outsourcing on cross-functional clinical trial working group meetings. Assist in the monthly accrual process and financial reporting for projects Assist Director with departmental process improvements as needed Work in collaboration with Compliance on FMV; May help train individual contributor/professional employees Required Knowledge, Skills, and Abilities Bachelor's degree with three years of clinical outsourcing experience Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization Experience generating RFPs, RFIs, and study budget/contract templates Proven track record negotiating contracts and budgets with both U.S. and international vendors In-depth knowledge of compliance and legal issues related to the conduct of clinical trials phase 1 - 3. Experience with post authorization phase 4 preferred. Experience managing CROs, central laboratories, and other clinical study vendors, including trial sites a plus. Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety Ability to prioritize and handle multiple tasks simultaneously Maintain up to date information on changing healthcare regulations affecting clinical trial payments Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees. Some limited travel may be required 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: .
Dec 11, 2025
Full time
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 for more information. Brief Description: The Manager, Clinical outsourcing will manage the clinical trial outsourcing for Jazz Pharmaceuticals' clinical development programs across clinical study phases pre- and post-authorization. Under the direction of the Associate Director, Clinical Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of Jazz' clinical studies. Essential Functions Assist Associate Director and senior leadership in the management of the outsourcing, vendor selection and clinical contracts process Generate RFIs, RFPs, and contract templates Negotiate and maintain clinical development contracts, including vendor CDAs, MSAs investigator meeting agreements, Statements of Works for external clinical service providers, consultant agreements and specialty vendor contracts Oversee CRO/FSP activities in regard to CDAs, vendor Statements of Work and clinical site agreements Submit purchase requisitions and manage contract approvals through Jazz's S2P system Interface with cross-functional teams, including legal, procurement, compliance and clinical operations functions in selection and management of vendors and study sites Manage selection process and develop strong relationships with vendors in conjunction with cross-functional teams Organize bid defense meetings as required Develop and maintain tracking tools (spreadsheets, databases, etc.), Attend team meetings as appropriate, represent Clinical outsourcing on cross-functional clinical trial working group meetings. Assist in the monthly accrual process and financial reporting for projects Assist Director with departmental process improvements as needed Work in collaboration with Compliance on FMV; May help train individual contributor/professional employees Required Knowledge, Skills, and Abilities Bachelor's degree with three years of clinical outsourcing experience Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization Experience generating RFPs, RFIs, and study budget/contract templates Proven track record negotiating contracts and budgets with both U.S. and international vendors In-depth knowledge of compliance and legal issues related to the conduct of clinical trials phase 1 - 3. Experience with post authorization phase 4 preferred. Experience managing CROs, central laboratories, and other clinical study vendors, including trial sites a plus. Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety Ability to prioritize and handle multiple tasks simultaneously Maintain up to date information on changing healthcare regulations affecting clinical trial payments Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees. Some limited travel may be required 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: .
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. You will be responsible for the management and oversight of the activities performed by ICSR Quality Control resources, Managed Services and QA & Compliance Oversight team. The incumbent Interfaces to support PV Operations strategy and initiatives. Key Responsibilities Accountable for Case Management's outsourcing strategy to support new acquisitions, integrations, expansion into new regions and company growth. Strategic Oversight of Global Case Management Pharmacovigilance vendors as it relates to governance, financials, contracts, reporting, training, and resourcing. Strategic Oversight of Global ICSR Quality Assurance activities. Oversight of Global ICSR Reconciliation activities. Develop and maintain workload metrics related to case volume and resources; adjust workload distribution and vendor resources based on existing or anticipated changes to case volume in order to maintain compliance and overall quality. Develop and/or update existing standard operational procedures (SOPs) for relevant functional responsibilities. Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required. Skills and Experience Required Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations. Experience working with third parties (e.g., contract service providers) and relationship management Qualifications and Education Required BS/BA, RN, Pharmacist, or equivalent. Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
Nov 17, 2025
Full time
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. You will be responsible for the management and oversight of the activities performed by ICSR Quality Control resources, Managed Services and QA & Compliance Oversight team. The incumbent Interfaces to support PV Operations strategy and initiatives. Key Responsibilities Accountable for Case Management's outsourcing strategy to support new acquisitions, integrations, expansion into new regions and company growth. Strategic Oversight of Global Case Management Pharmacovigilance vendors as it relates to governance, financials, contracts, reporting, training, and resourcing. Strategic Oversight of Global ICSR Quality Assurance activities. Oversight of Global ICSR Reconciliation activities. Develop and maintain workload metrics related to case volume and resources; adjust workload distribution and vendor resources based on existing or anticipated changes to case volume in order to maintain compliance and overall quality. Develop and/or update existing standard operational procedures (SOPs) for relevant functional responsibilities. Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required. Skills and Experience Required Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations. Experience working with third parties (e.g., contract service providers) and relationship management Qualifications and Education Required BS/BA, RN, Pharmacist, or equivalent. Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
