REMS Operations Lead: Strategy & Execution (Remote)

BioSpace; California; Remote; USD 142,000 - 212,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) retirement savings plan

Flexible paid vacation

Job summary

Jazz Pharmaceuticals is seeking a Senior Manager, REMS Operations to oversee U.S. FDA-mandated REMS programs.

Based in California with remote capabilities, you will ensure regulatory compliance, coordinate governance, and lead cross-functional execution. Responsibilities include managing day-to-day REMS operations, strategic oversight, risk monitoring, vendor collaboration, and maintaining documentation for inspections.

Qualifications

• 4–6 years in the pharmaceutical industry.
• Experience with REMS and vendor management preferred.
• At least 2 years of project or program management experience.
• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
• Excellent oral and written communication; highly organized.
• Self-sufficient in a remote work environment.

Responsibilities

• Manage day-to-day operations of the U.S. REMS programs, ensuring regulatory compliance.
• Provide strategic oversight of REMS initiatives and alignment to priorities.
• Coordinate REMS governance and operational workstreams, including agendas, meetings, timelines, minutes, and action follow-ups.
• Monitor REMS program health, identify risks, dependencies, and implement mitigation strategies.
• Partner with cross-functional teams and external vendors to execute REMS requirements.
• Maintain documentation and records for regulatory inspections, audits, and governance activities.

Skills

REMS management

Vendor management

Project management

MS Office

Communication

Organization

Remote work

Education

Bachelor's degree

Tools

MS Office

Job description

Jazz Pharmaceuticals is seeking a Senior Manager, REMS Operations to oversee U.S. FDA-mandated REMS programs.

Based in California with remote capabilities, you will ensure regulatory compliance, coordinate governance, and lead cross-functional execution. Responsibilities include managing day-to-day REMS operations, strategic oversight, risk monitoring, vendor collaboration, and maintaining documentation for inspections.