Senior REMS Operations Manager | Regulatory & Vendors

Jazz Pharmaceutical

United States

Remote

USD 142,000 - 212,000

Full time

9 days ago
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Benefits offered by this job

Discretionary bonus
Equity grants
Health benefits

Job summary

Jazz Pharmaceuticals is seeking a Senior Manager, REMS Operations to lead the operational oversight and execution of U.S. FDA‑mandated REMS programs. You will drive governance, vendor performance, and timely deliverables while advancing program effectiveness.

You will collaborate with internal stakeholders and external REMS vendors, ensuring regulatory compliance and continuous process improvement in a remote work environment.

Qualifications

  • Minimum 4–6 years in the pharmaceutical industry.
  • Experience in REMS and vendor management preferred.
  • Minimum 2 years of project and/or program management experience.
  • Proficient in Word, Excel, PowerPoint, Outlook.

Responsibilities

  • Manage day-to-day operations of U.S. FDA‑mandated REMS programs with governance standards.
  • Provide strategic oversight to ensure timely program objectives.
  • Coordinate REMS governance and operational workstreams, including agendas and minutes.
  • Monitor REMS program health, identify risks, and implement mitigations.
  • Collaborate with cross‑functional teams and external vendors to meet requirements.
  • Maintain documentation for inspections, audits, and governance.

Skills

REMS management
Vendor management
Project management
Regulatory knowledge
Communication
MS Office
Remote work discipline

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Jazz Pharmaceuticals is seeking a Senior Manager, REMS Operations to lead the operational oversight and execution of U.S. FDA‑mandated REMS programs. You will drive governance, vendor performance, and timely deliverables while advancing program effectiveness.

You will collaborate with internal stakeholders and external REMS vendors, ensuring regulatory compliance and continuous process improvement in a remote work environment.

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