REMS Operations Lead: Strategy & Compliance

Jazz Pharmaceuticals; United States; Remote; USD 128,000 - 192,000; Full time

Benefits offered by this job

Discretionary annual bonus

Medical, dental, and vision insurance

401(k) retirement savings plan

Job summary

Jazz Pharmaceuticals, Inc. is seeking an experienced REMS Program Manager to oversee day-to-day operations for U.S. FDA–mandated REMS programs, ensure regulatory compliance, and align initiatives with business priorities.

The role requires 4–6 years in pharma, 2+ years in PM/Program Management, remote-work discipline, and strong MS Office skills; base pay ranges from $128k to $192k with benefits.

Qualifications

• Minimum 4–6 years in the pharmaceutical industry.
• Experience in REMS is preferred.
• Minimum 2 years of pharmaceutical Project and/or Program Management experience.
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook.
• Excellent oral and written communication skills.

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.

Skills

Project management

REMS experience

Cross-functional collaboration

MS Office

Excellent communication

Remote work discipline

Education

Bachelor's degree

Tools

Microsoft Office Suite

Job description

Jazz Pharmaceuticals, Inc. is seeking an experienced REMS Program Manager to oversee day-to-day operations for U.S. FDA–mandated REMS programs, ensure regulatory compliance, and align initiatives with business priorities.

The role requires 4–6 years in pharma, 2+ years in PM/Program Management, remote-work discipline, and strong MS Office skills; base pay ranges from $128k to $192k with benefits.