What are the responsibilities and job description for the Senior Medical Review Coordinator position at Indegene?
Senior Medical Review Coordinator – Hybrid to either Foster City (CA), Parsippany (NJ), or Raleigh (NC)
-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 (Medical Review Committee)
- 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
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
