Remote-Ready REMS Operations Manager

BioSpace

Palo Alto (CA)

Remote

USD 128,000 - 192,000

Full time

5 days ago
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Job summary

Jazz Pharmaceuticals is seeking a REMS Program Manager to oversee day‑to‑day REMS operations and ensure regulatory compliance for U.S. programs. You will coordinate governance, manage timelines, and document actions with cross‑functional teams and external vendors.

The role requires 4–6 years in pharma, REMS experience preferred, and at least 2 years in project/program management, plus strong communication skills and MS Office proficiency. Remote work readiness is essential.

Qualifications

  • A minimum of 4–6 years of experience in the pharmaceutical industry.
  • Experience in REMS 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.

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

Regulatory compliance
Program management
Cross-functional collaboration
MS Office
Communication
Attention to detail
Remote work discipline

Education

Bachelor's degree in relevant field

Tools

Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook

Job description

Jazz Pharmaceuticals is seeking a REMS Program Manager to oversee day‑to‑day REMS operations and ensure regulatory compliance for U.S. programs. You will coordinate governance, manage timelines, and document actions with cross‑functional teams and external vendors.

The role requires 4–6 years in pharma, REMS experience preferred, and at least 2 years in project/program management, plus strong communication skills and MS Office proficiency. Remote work readiness is essential.

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