Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development Serve as the Regulatory Affairs representative on project teams; assure the progress of projects by providing direction, solutions, and feedback to the teams Lead regulatory interactions with health authorities, marketing partners, and vendors for their products

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, 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 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

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

Strategic Leadership Provide strategic direction and leadership for the clinical development of BTC and GEA Oncology program, aligning with overall corporate goals and objectives. Clinical Development Planning Develop and execute comprehensive Global clinical development plans for Oncology in the context of BTC and GEA, including study design, protocol development, and re

The Director, Toxicology is accountable for managing the global nonclinical regulatory and investigative toxicology of assigned Jazz portfolio products, and likewise to support his/her reports overseeing those products. They will collaborate with their direct reports and other members of the toxicology group, Early Development non clinical scientists, and members of Jazz

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

The Executive Director, Late Stage Oncology Clinical Operations will lead a team of clinical operations professionals charged with the execution and delivery of our Oncology Phase 1 3 pipeline. S/he must have extensive knowledge and experience in solid tumor clinical development from planning through approvals. This includes strategic operational planning, project cost es

include leading the development of launch marketing strategies and tactics across all audiences oncologists, patients, advanced practice providers, pathologists and so on. The candidate will eventually be responsible for hiring and managing Product Managers / Senior Product Managers as launch readiness shifts into execution. The Director will work closely with a wide range

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