Senior REMS Project Management

Description

• 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.

Qualifications

• 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.