Medical Affairs Manager Jobs

This position will be responsible for leading and managing the operational execution of Medical Review Committee (MRC), and various Medical Affairs Operations support.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.

Skills:

• Tracks electronic review cycle and adherence to MRC calendars and timelines.
• 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.
• Fosters teamwork and collaboration, coordinate cross-functional team efforts.
• 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.
• Assists with FDA audits or other legal issues as needed.
• Provide MRC SOP and system training to key stakeholders and agencies.
• Ensure projects are completed on schedule following established procedures and timelines.
• Records action plans and follow-up accordingly with MRC members.
• Provides input on workflow planning and prioritization.
• Ensure timely distribution of material to be reviewed.
• Manage vendors and oversee projects in support of Medical Affairs, including but not limited to MRC, and Medical Affairs Operational support.
• Proactively provides logical recommendations and solutions.
• 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.
• 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.
• Drives adherence with MRC SOP to improve MRC coordination and streamline MRC work processes.
• Review all MRC submissions for completeness and accuracy.
• 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.

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.