Manager, REMS Operations

🔥 0 minutes ago

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $128k - $192k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

🦅 H1B Visa Sponsor

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Support the day-to-day operations of U.S. FDA-mandated REMS programs and ensure compliance with regulatory requirements and internal governance standards • Provide strategic oversight of REMS initiatives and align program execution with organizational priorities • Coordinate REMS governance and operational workstreams, including agenda development, meeting facilitation, timeline management, meeting minutes, and action-item follow-up • Monitor REMS program health by identifying risks, dependencies, resource constraints, and operational issues • Implement mitigation strategies to support business continuity • Support development, staging, review, communication, and approval of REMS materials • Partner with cross-functional teams and external vendors to execute REMS program requirements • Maintain accurate documentation and records for regulatory inspections, audits, and internal governance activities

🎯 Requirements

• 4–6 years of experience in the pharmaceutical industry • Minimum 2 years of pharmaceutical project and/or program management experience • Experience in REMS preferred • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook • Excellent oral and written communication skills • Highly organized with consistent attention to detail • Self-sufficient and disciplined for a remote work environment • Bachelor's degree or equivalent in a relevant field required

🏖️ Benefits

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation