[Hiring] Manager, REMS Operations @Jazz Pharmaceuticals

Role Description

• 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.

Qualifications

• A minimum of 4-6 years of experience in the pharmaceutical industry.
• Experience in REMS is preferred.
• 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.

Requirements

• Bachelor's degree (or equivalent) in relevant field, required.

Benefits

• Medical, dental and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.
• Discretionary annual cash bonus or incentive compensation (depending on the role).
• Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.