Manager, REMS Operations
Jazz Pharmaceuticals•Palo Alto, CA
•$128,000 - $192,000•Remote
About The Position
Jazz Pharmaceuticals is a global biopharma company focused on innovating to transform the lives of patients with serious diseases. They develop life-changing medicines, with a portfolio including therapies for sleep disorders and epilepsy, and a growing focus on cancer treatments. Their patient-focused, science-driven approach fuels research and development in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland, with global operations.
Requirements
- A minimum of 4-6 years of experience in the pharmaceutical industry.
- A minimum of 2 years of pharmaceutical Project and/or Program Management experience
- Proficient in Microsoft tool suite (Word, Excel, PowerPoint, Outlook).
- Excellent oral and written communication skills.
- Highly organized and demonstrates consistent attention to detail.
- Self-sufficient/discipline for remote work environment.
- Bachelor's degree (or equivalent) in relevant field, required
Nice To Haves
- Experience in REMS is preferred.
Responsibilities
- Support 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 initiatives, ensuring timely execution of program objectives and alignment to organizational priorities.
- Coordinate REMS governance and operational workstreams, including agenda development, meeting facilitation, timeline management, documentation of meeting minutes, and follow-up on action items with cross-functional stakeholders.
- Monitor overall REMS program health by proactively identifying risks, dependencies, resource constraints, operational issues, and implementing mitigation strategies to support business continuity.
- Support the development, staging, review, communication of modification and approval of REMS materials.
- Partner with cross-functional teams and external vendors to execute REMS program requirements and drive operational excellence.
- Maintain accurate documentation and records to support regulatory inspections, audits, and internal governance activities.
Benefits
- medical, dental and vision insurance
- 401k retirement savings plan
- flexible paid vacation
- discretionary annual cash bonus or incentive compensation
- discretionary equity grants
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What This Job Offers
Job Type
Full-time
Career Level
Manager
