Senior Manager, REMS Operations

About this role

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma 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 diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. As a member of the REMS Strategy and Operations team, the Senior Manager, REMS Operations role is responsible for supporting the operational oversight, and execution of all U.S. FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs for Jazz Pharmaceuticals. This role provides end-to-end operational management for REMS programs by ensuring compliance with regulatory requirements, driving governance, mitigating operational risk, and fostering cross-functional collaboration with internal stakeholders and external REMS vendors. This role oversees REMS operational planning and execution, coordinates governance and operational activities, manages vendor performance, and ensures timely completion of program deliverables while supporting continuous process improvement and overall program effectiveness. Essential Functions/Responsibilities Manage the day-to-day operations of the U.S. FDA–mandated REMS programs, ensuring compliance with regulatory requirements and internal governance standards. Provide strategic oversight of REMS ini...