Title:  Senior MRC Coordinator

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