Medical Program Manager

UCBRaleigh, NC
7hHybrid

About The Position

The Medical Program Manager serves as a central operational and strategic partner within the U.S. Rare Diseases Medical Affairs team. This individual ensures seamless coordination and support of a REMS program, organization and budget management of the yearly medical plans for both MG and MOGAD, and other pillars within the rare disease organization. The role requires exceptional organizational skills, attention to detail, and the ability to manage multiple priorities in a dynamic environment.

Requirements

  • Bachelor’s degree required; advanced degree (MBA, MPH, or MS) preferred.
  • 5+ years of experience in program or project management within pharmaceutical, biotech, or healthcare organizations.
  • Proven understanding of Medical Affairs functions including evidence generation, scientific communications, and medical information.
  • Proficiency in Microsoft Office Suite, SharePoint, and project management tools (e.g., Smartsheet, Planview, or equivalent).

Nice To Haves

  • Experience supporting REMS or similar post-marketing compliance programs strongly preferred.
  • Familiarity with systems such as MedSource, Veeva CRM, and SourceClear a plus.

Responsibilities

  • Participate in and support recurring project and program meetings across the Medical Affairs team.
  • Maintain and update program management tools including the medical plan program planner, individual project trackers, and SharePoint lists.
  • Coordinate documentation and governance activities associated with the REMS program, including meeting minutes, quality management, and tracking of corrective and preventive actions.
  • Support inspection readiness activities, including preparation of audit materials, cross-functional coordination, and document archiving.
  • Provide logistical and administrative support for ad hoc scientific meetings, survey methodology documentation, and training curriculum development.
  • Maintain budget trackers, purchase orders, and yearly Integrated Strategic Plan (ISP) budget planning documents.
  • Track and report program spending and vendor utilization for both medical affairs and REMS-related activities.
  • Conduct weekly 1:1 alignment meeting with each team member to ensure coordination and follow-up across all Rare Medical initiatives, including gMG and MOGAD.
  • Support the Rare Medical team through SourceClear submissions, CRM uploads for congress deliverables, and operational management of assigned tasks.
  • Manage SourceClear job creation and submission for MOGAD and other relevant projects.
  • Coordinate communication between Global and U.S. Medical Information, including routing of letters through MedSource and ensuring compliance with local review processes.
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