Skip to content

Job Openings

Remote Senior Manager, Global Medical Affairs, Medical Review Commitee

San Mateo, CA 94404

Posted: 06/21/2023 Employment Type: Contract Job Category: Medical Affairs Job Number: 562433-1 Is job remote?: Yes Country: United States

Job Description

Pay 50-70/h depending on experience

  • 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.
Requirements:
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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About San Mateo, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Mateo, California area today! Located in the heart of the Bay Area, San Mateo offers a perfect blend of picturesque landscapes, bustling tech industry, and a rich cultural scene. From the iconic Coyote Point Park to the bustling downtown with its array of dining options, art galleries, and theaters, there is something for everyone here. With proximity to professional sports teams like the San Francisco Giants and Warriors, as well as easy access to the stunning Half Moon Bay and Pacific Ocean beaches, San Mateo provides a unique backdrop for career growth and personal enjoyment. Don't miss out on the chance to make your mark in this dynamic and inviting community!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.