Senior Manager, REMS Operations

Jazz Pharmaceuticals; California, Northern (MO, KY); Hybrid; USD 95,000 - 130,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a Senior Manager to lead REMS Operations in the United States, overseeing FDA-mandated REMS programs and ensuring regulatory compliance. The role drives governance, risk mitigation, and cross-functional collaboration with internal teams and external vendors.

The position supports end-to-end REMS program execution, maintaining documentation for inspections and audits, and advancing continuous process improvements within a remote work environment.

Qualifications

• 4–6 years of experience in the pharmaceutical industry.
• Experience in REMS and vendor management is preferred.
• 2 years of pharmaceutical Project and/or Program Management experience.
• Proficient in Microsoft tool suite (Word, Excel, PowerPoint, Outlook).

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 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.
• 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

Project management

Vendor management

Communication

Attention to detail

Remote work discipline

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

As a member of the REMS Strategy and Operations team, the Senior Manager, REMS Operations roleis 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 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.
• 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.

Required Knowledge, Skills, and Abilities

• A minimum of 4-6 years of experience in the pharmaceutical industry.
• Experience in REMS and vendor management 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.

Required/Preferred Education and Licenses

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