Note: The job is a remote job and is open to candidates in USA. Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Manager of REMS Operations will oversee the U.S. FDA-mandated REMS programs, ensuring compliance and strategic alignment with organizational priorities.
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
Skills
- 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
- Experience in REMS is preferred
Benefits
- Discretionary annual cash bonus or incentive compensation (depending on the role) (per the Company's Global Cash Bonus Plan or Incentive Compensation Plan)
- Discretionary equity grants (per Jazz’s Long Term Equity Incentive Plan)
- Medical, dental and vision insurance
- 401k retirement savings plan
- Flexible paid vacation
Company Overview