Senior REMS Project Management

Role Summary

Senior Manager REMS Project Management will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. This role supports the Director level of the REMS Strategy and Operations department in multiple initiatives in the US, providing management and ongoing development and review of REMS documents and related materials, FDA information requests, and coordinating REMS team meetings with internal Jazz teams, external REMS administrators, or REMS vendors. The role will provide information on ongoing projects to senior management and support presentation development and delivery to senior leadership.

Responsibilities

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

Qualifications

• Required: A minimum of 4-6 years of experience in the pharmaceutical industry, with 2-3 years’ experience in REMS is preferred.
• Required: A minimum of 2 years pharmaceutical Project Management experience.

Skills

• Ability to create high-quality PowerPoint presentations to support executive communication and project updates, including layout design, visual storytelling, and template creation.
• Proficient 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.

Education

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