Title:  Senior MRC Coordinator

Date:  Mar 3, 2025
Location: 

NJ, US

Senior MRC Coordinator

  • Process Management - Effectively and efficiently facilitate the content review process from submission through content dissemination. Activities include but not limited to:
    • Determines if Materials are within scope for MRC
    • Determines if Materials are ready for MRC review and meet MRC submission
    • criteria (review MRC submission checklist prior to sending for review and approval)
    • Develops and communicates agenda for MRC meetings to all attendees
    • Manages effective dates and expirations communications to Document Owner
  • Review Platform Utilization - Routing documents as outlined in SOP; Reporting; Managing expiry process
  • Editorial Support - Conducting post-review check to ensure changes were incorporated (if needed)
    • QC of annotations and tagging and linking references as per best practice guidance documents
    • Performs quality check post-MRC review to ensure all reviewer comments have been implemented correctly
    • Performing final editorial review/quality check
  • Meeting Management
    • Scheduling recurring MRC review meetings, ad hoc, and escalation meetings, as needed
    • Coordinating meeting logistics; Coordinate the agenda and facilitates standing MRC meetings with
      the Document Owner and MRC to resolve comments and questions
    • Preparing agendas; Facilitating MRC meetings; Annotating (documenting notes/action items)
      during review meetings
    • Perform post-meeting activities (e.g., preparing and disseminating meeting minutes; follow-up on action item completion)

Qualifications

  • Have at least 5 years of experience in coordinator/project manager role for PRC and/or MRC in pharmaceutical industry
  • Strong meeting facilitation skills, including ability to clearly document/annotate key decisions/outcomes in Veeva MedDocs during live meetings.
  • Strong communication skills