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The Manager, Federal Contract Operations is responsible for assisting with all federal program contracts (Medicaid, Medicare GAP, Tricare, Vial Wastage and Inflation Rebates). The individual will also have the responsibility of performing support analytics for the SOX and GTN teams through compiling, analyzing and interpreting both internal and secondary data sources and
Posted 2 days ago
The Senior Manager, Regulatory Information Management (RIM), will work closely with R&D and Manufacturing well as other functions within Jazz, to manage training, documentation, user experience, and maintenance of the RIM system and integration with the other systems at Jazz Essential Functions Understand the business processes (across R&D and Manufacturing), regulatory a
Posted 2 days ago
The Manager of Global Medical Affairs, Independent Medical Education (IME) Grants will be responsible for the successful development and management of the global medical education grant program for assigned therapeutic areas (Tas). The position will support delivery of impactful medical education that enhances patient care by improving Healthcare Professionals' ability to
Posted 5 days ago
The Director, Global Medical Affairs Neuroscience Sleep (Dir GMA) is a key member of Jazz's Global Medical Affairs department, reporting directly to Global Medical Affairs Molecule Lead (GMAL), Sleep. As a subject matter expert for sleep, they will hold a key leadership position and be responsible for developing, in coordination with the GMAL, an integrated Global Medical
Posted 5 days ago
The Director will be responsible for managing the product leaders and external FSP personnel, overseeing all ongoing clinical studies, and planning the operational aspects of all new clinical studies. The Director will support Integrated Data Analytics and Statistical Programming in statistical analysis and oversee statistical programming activities for all clinical studi
Posted 7 days ago
may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands. Frequent public contact requiring appropriate business apparel. 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, n
Posted 9 days ago
The primary responsibility of this position is to provide guidance to MSLs in cultivating current and future thought leaders in academic and clinical medicine at the local, regional, and national levels in the field of Hematology Oncology. The MSL Associate Director will lead, manage, coach, train, and develop MSL direct reports to support high performance, and to align w
Posted 9 days ago
The Associate Medical Director, Jazz Oncology, Medical Aairs will support US Medical Aairs activities related primarily to HER2+ target therapy in Gastroesophageal adenocarcinoma (GEA) and secondarily only as it is needed in Biliary tract cancers (BTCs). This is an expert scientific and medical leadership position that develops and maintains non promotional, evidence base
Posted 13 days ago
This individual will require an understanding of the scope of Medical Affairs training and excellence as well as excellent organizational and project management skills. The position will deliver by building strong relationships with key partners in a highly matrixed team environment. This role is accountable for executing the US Medical Affairs (USMA) training objectives,
Posted 16 days ago
Jazz Pharmaceuticals
- Philadelphia, PA / Carlsbad, CA
Write and edit lean clinical regulatory documents companywide for sense, clarity, accuracy. Provide writing support for a wide range of documents, including investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. Work with the lead writer to create, manage and communicate the document timeline to ensure all revie
Posted 18 days ago
The Manager, Data Management & Operations will bring data management experience and technical skills to manage the end to end life cycle of commercial data. The Data Management and Operations Role function is to set up proactive data quality checks, act as data stewards, focused on the day to day data operations & management tasks. This work will require collaboration wit
Posted 18 days ago
Attend multi disciplinary team meetings, representing the CDI&S function. Create or review and approve statistical programming plans at study and project level. Provide input on key study related documents produced by other functions (e.g. CRFs, Data Management Plan, etc.). Create or review and approve CDISC compliant datasets and corresponding documentation for electroni
Posted 18 days ago
Provide subject matter expertise (SME) in Biologics Formulation and DP process development including lyophilized presentation development. Author and review CMC modules of IND and BLA filings Support tech transfer of biologics drug product processes to commercial scale contract manufacturing organizations (CMOs) Serve as Person in Plant (PiP) during batch production to ac
Posted 20 days ago
The Statistical Programming Group within the Department of Biometrics is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines. Essential Functions Attend multi disciplinary team meetings, representing the programming function. Create or review and approve programming plans at study and project leve
Posted 20 days ago
The Integrated Data Analytics and Statistical Programming Group (IDASP) within the Department of Data sciences is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines. Essential Functions Attend multi disciplinary team meetings, representing the programming function. Create or review and approve pr
Posted 24 days ago
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