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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 Today
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 2 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 2 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 6 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 9 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 11 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 11 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 11 days ago
The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for all statistical aspects of study design, study analysis an
Posted 13 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 13 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 13 days ago
The Director, Medical Communications is responsible for the development of medical publications as well as the management of publication agencies/vendors and the associated budgets, and oversight of internal medical writer led projects. This role collaborates with the medical communication lead for the therapeutic area, the Global Medical Affairs Lead (GMAL), and addition
Posted 16 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 17 days ago
The Senior Manager, Pharmacology Scientist directs, leads, and manages Jazz non clinical Pharmacology projects from conceptualization and study design through to study report finalization and subsequent scientific publications, and inclusion in regulatory documentation. Manages interactions and collaboration with key stakeholders within non clinical and across the wider o
Posted 20 days ago
The position will be accountable for delivering field force analytics and operational effectiveness in support of the ONC BU under the US Business Operations and Analytics department. Responsibilities include field target planning and alignment, field process optimization, field analytics and performance measurement, field force data and technology solutions, and incentiv
Posted 23 days ago
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