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,

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

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

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

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

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

Development of the pharmacometrics strategy of multiple programs Design, perform, interpret and report population PK, PK/PD and exposure response analyses Provide hands on population PK and PK/PD modeling and simulation support for development projects, e.g., dose selection and optimization Clinical study protocol design, data analysis/interpretation, and reporting of stu

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

If you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ JAZZ) is a global biopharmaceutical 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

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

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

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

If you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ JAZZ) is a global biopharmaceutical 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

Support information security risk management programs. Be the advocate for information security risk management, engage with stakeholders, supports the identification of security risks and risk exceptions to treatment. Ensure identified security risks impacting the company are effectively evaluated and communicated. Collaborate with stakeholders on remediation and risk mi

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