Senior Manager, REMS Operations

Jazz Pharmaceuticals; California; Remoto; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Jazz Pharmaceuticals seeks a Senior Manager, REMS Operations to lead the operational oversight and execution of U.S. FDA-mandated REMS programs.

You will ensure regulatory compliance, drive governance, and coordinate across internal teams and external vendors to deliver program objectives. The role requires 4–6 years in pharma, REMS or vendor management experience, and strong program management and communication skills.

Competenze

• Bachelor's degree in a relevant field is required.
• 4–6 years in the pharmaceutical industry.
• Experience with REMS programs and vendor management preferred.
• Strong communication and organizational skills.

Mansioni

• Oversee day-to-day REMS operations in the U.S.
• Provide strategic oversight of REMS initiatives and governance.
• Coordinate cross-functional and vendor activities and meetings.
• Maintain documentation for inspections, audits, and governance.

Conoscenze

Program management

Regulatory compliance

Vendor management

Cross-functional collaboration

Communication skills

Remote work discipline

Formazione

Bachelor's degree

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Descrizione del lavoro

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