This position will provide a strategic leadership in design, oversight, analysis and reporting of pharmacometrics programs to support small and large molecule compounds in oncology from discovery through registration and post marketing. Essential Functions This position has varying responsibilities relating to clinical pharmacology, pharmacokinetics (PK), and pharmacodyna

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

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

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

Innovative Solution Delivery Conceptualize, create, and implement cutting edge and interactive solutions to enhance customer experience within the Sleep business unit. Data & Analytics Incorporate a robust focus on data analytics and real time solution design within technology solutions. Work seamlessly with cross functional teams to achieve successful outcomes, utilizing

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

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 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

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

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