Senior REMS Project Management

As a member of the REMS Strategy and Operations department, the Senior Manager REMS Project Management will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. This role will support the Director level of the department in multiple department initiatives in the US. This role provides management and ongoing development and review of staging of REMS Document and related materials, FDA information requests, coordinating, and managing related REMS team meetings for internal Jazz teams, external REMS administrator, or REMS vendors. Role will provide information of ongoing projects and initiatives to senior management as required. Support presentation development and delivery to senior leadership.

Essential Functions/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.

Required Knowledge, Skills, and Abilities:

• 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.

Required/Preferred Education and Licenses

Bachelor's degree (or equivalent) in relevant field, required

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