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

The Associate Director, Compliance & Ethics Data Analysis and Operational Excellence reports to the VP, Chief Compliance & Ethics Officer and is responsible for managing the data analytics and system modernization efforts to improve the effectiveness of Jazz's Compliance & Ethics program [referred to as I CARE (Integrity, Compliance, Accountability, Respect and Ethics)].

Support the development and deployment of the long term training, policy, and communications strategy for the I CARE program, while performing the day to day tasks required Oversee Jazz's global I CARE policy governance framework Setup and lead a cross functional I CARE Policy Management Network, in collaboration with global business functions and I CARE business partners

Partners with PV system stakeholders in R&D, Tech Ops and Commercial to monitor trends in regulatory inspection activities to proactively identify potential areas of risk, and develop proposals to mitigate against such risks. Collaborates with local site teams (e.g., IT, Facilities, R&D, Administrative Support, etc.) to ensure logistical support during inspections and aud

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

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

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

Provide field based scientific exchange and communication of FDA approved and pipeline products In support of FDA approved products, work within the Medical Science Liaison team's objectives Identify, establish, and maintain scientific relationships withopinion leaders regarding disease state and product specific information Facilitate scientific development of pipeline c

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

The Late Development Team Lead (LDTL) is a critical role in the organization that has a significant impact on the late product lifecycle of a product or platform of products. The LDTL is accountable for leading the Late Development Team (LDT) in establishing and executing on a global product(s) strategy, which integrates scientific rationale, clinical development, nonclin

Excellent working knowledge on pharmacovigilance and drug safety regulations (ICH, GxP) Work to streamline and optimize business processes based on industry best practices. Generate listings from the safety database, both standard reports and ad hoc queries. Conduct peer review of safety database queries for accuracy and completeness of the results. Coordinate safety syst

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

may require a work schedule that may include working outside of "normal" work hours, to meet business demands. Occasional 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, national

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