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As a Temp Medical Review Committee (MRC) Specialist you are responsible for coordinating our MRC activities and ensuring the production of high quality, compliant materials in a timely and efficient manner. You will track scientific materials from inception through approval, maintaining appropriate systems and documentation files. This is all accomplished while ensuring all applicable company polices and guidelines are followed. Additionally, you will be maintaining and making sure associated operating procedures are followed, managing high-level committee meetings, ensuring continued compliance with all laws, policies and procedures, and providing guidance to material sponsors on timelines.
A typical day may include:
Ensure adherence to MRC and oversee the review and approval process through electronic review system (Veeva Vault)
Prepare for and actively participate in any and all QC checks and/or audits.
Proactively manage all files and systems needed to support the MRC review process
Assist in the maintenance of the Medical Reference Library and ensure that library is kept current and free of duplicates
Review materials submitted for MRC to assess for appropriateness and completeness prior to routing submissions for review; provide proactive guidance on submissions where needed prior to MRC approval
Provide material sponsors with expiration reports to ensure all materials, if needed, are scheduled for a timely annual review prior to expiration
This may be for you if you:
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