Title: Senior MRC Coordinator
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