Manager, REMS Operations

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.

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.

Requirements

• 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.

Qualifications

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

Pay

For this role, the full and complete base pay range is: $128,000.00 - $192,000.00. Individual compensation paid within this range will depend on factors including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

Benefits

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

For more information on our Benefits offerings please visit Jazz Pharmaceuticals Benefits.