Medical Affairs, Medical Review Commitee

Title: Global Medical Affairs, Medical Review Commitee

Location: 1840 Gateway Drive, 3rd Floor, San Mateo, CA

Duration: Contract

Skills:

• Records action plans and follow-up accordingly with MRC members.
• Ensure projects are completed on schedule following established procedures and timelines.
• Drives adherence with MRC SOP to improve MRC coordination and streamline MRC work processes.
• Provide MRC SOP and system training to key stakeholders and agencies.
• Provides input on workflow planning and prioritization.
• Review all MRC submissions for completeness and accuracy.
• Proactively provides logical recommendations and solutions.
• Assist with ad-hoc medical affairs projects and program management.
• 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.
• Ensure timely distribution of material to be reviewed.
• Ensure that the records for potential FDA audits are accurate, complete, and reflect the company SOP.
• Manage vendors and oversee projects in support of Medical Affairs, including but not limited to MRC, and Medical Affairs Operational support.
• Assists with FDA audits or other legal issues as needed.
• Supports and keeps Director informed on plans and coordination of projects.
• Manage strong relationships with the vendors/agencies responsible for MRC system management and agencies working on material development.
• Fosters teamwork and collaboration, coordinate cross-functional team efforts.
• 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.
• Tracks electronic review cycle and adherence to MRC calendars and timelines.
• Facilitate review meetings including recording MRC comments.
• Manage all aspects of Medical Review Committee.
• Works with medical communications lead and any relevant external partner agencies to implement revisions and resubmissions as needed for MRC.

Education: 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.

Apply to [email protected]

If you are NOT interested, please forward the details to your friends and colleagues that may fit.

I can pay a SUBSTANTIAL REFERRAL