Senior REMS Project Management

Jazz Pharmaceuticals is a global biopharma company dedicated to innovating life-changing medicines for patients with serious diseases. The Senior Manager REMS Project Management will support FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs, manage project documentation, and facilitate communications with stakeholders.

Responsibilities:

• Support the execution and operational management of U.S. FDA–mandated REMS programs through effective project management at Jazz Pharmaceuticals
• Responsible for the preparation and coordination of REMS regulatory documentation, including tracking submission timelines, managing agency requests and responses, and ensuring timely follow-up, resolution, and submission
• Ensures all submissions are complete, accurate, compliant, and delivered on time, while coordinating with cross-functional stakeholders and maintaining submission records
• Develop and manage the ongoing internal REMS required team meetings, external REMS administrator and vendor meetings, provide and manage team meeting notes, timelines and follow-ups with key contributors, as required
• Facilitate and lead complex, high-intensity meetings to achieve alignment on FDA-mandated Information Requests and the REMS submission process
• Maintain submission archives, documentation repositories, and version control
• Oversee development and/or modification of REMS stakeholder materials
• Upload and route all required REMS documents, materials and FDA Information Requests to internal Jazz stakeholders, as required
• Support daily department functions required to meet business and regulatory requirements within team and cross-functional activities

Requirements:

• A minimum of 4-6 years of experience in the pharmaceutical industry, with 2-3 years' experience in REMS is preferred
• A minimum of 2 years pharmaceutical Project Management experience
• Ability to create high-quality PowerPoint presentations to support executive communication and project updates, should include layout design, visual storytelling, and template creation
• 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
• Bachelor's degree (or equivalent) in relevant field, required