Remote Senior Manager, Global Medical Affairs, Medical Review Commitee
1840 Gateway Drive San Mateo, CA 94404 US
This position will be responsible for leading and managing the operational execution of Medical Review Committee (MRC), and various Medical Affairs Operations support of company products. Critical competencies include solid project management and time management skills, effective communication skills to engage key stakeholders, ensure cross-functional alignment, build and maintain strong and collaborative professional relationship with internal and external partners. This is a remote position, with no direct reports
- Manage vendors and oversee projects in support of Medical Affairs, including but not limited to MRC, and Medical Affairs Operational support.
- Manage strong relationships with the vendors/agencies responsible for MRC system management and agencies working on material development.
- Manage all aspects of Medical Review Committee.
- Drives adherence with MRC SOP to improve MRC coordination and streamline MRC work processes.
- Proactively provides logical recommendations and solutions.
- Tracks electronic review cycle and adherence to MRC calendars and timelines.
- Provides input on workflow planning and prioritization.
- Ensure projects are completed on schedule following established procedures and timelines.
- Review all MRC submissions for completeness and accuracy.
- Ensure timely distribution of material to be reviewed.
- Manage logistics of MRC meetings including creating the agenda and scheduling reviewers in coordination with MRC stakeholders from Medical Affairs, Regulatory Affairs and Compliance/Legal.
- Records action plans and follow-up accordingly with MRC members.
- Facilitate review meetings including recording MRC comments.
- Works with medical communications lead and any relevant external partner agencies to implement revisions and resubmissions as needed for MRC.
- Assists with FDA audits or other legal issues as needed.
- Ensure that the records for potential FDA audits are accurate, complete, and reflect the company SOP.
- Supports and keeps Director informed on plans and coordination of projects.
- Provide MRC SOP and system training to key stakeholders and agencies.
- Assist in the maintenance and update of Medical Affairs SOP for MRC review, and educate internal and external vendor partners on our procedures, processes, and company policies.
- Assist with ad-hoc medical affairs projects and program management.
- Fosters teamwork and collaboration, coordinate cross-functional team efforts.
Degree in a scientific discipline. 5-7 years of experience within the pharmaceutical industry, a consulting organization, and/or a medical communications company or as a project/program manager.
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