PRC Medical Reviewer

Consultant, Part-time PRC Medical Reviewer, Pharmaceuticals

 Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Medical Reviewer who can dedicate 15-25 hours per week hours/week as business needs dictate, to regulatory affairs, advertising, and promotional review of the client’s products.

Description

·      Conduct thorough regulatory reviews of promotional material for compliance with applicable FDA advertising and promotion regulations, including but not limited to:

·      Healthcare professional materials

·      Direct-to-consumer campaigns

·      Sales training materials

·      Disease awareness and unbranded campaigns

·      Corporate materials

·      Participate in cross-functional promotional review committees (PRC) as the Promotion

·      Compliance/Regulatory Advertising and Promotional reviewer.

·      Ensure promotional claims are consistent with approved labeling, supported by data, compliant with regulations, and consistent with company policy.

·      Maintain awareness of evolving FDA guidance and apply knowledge to ongoing review work (e.g., CFL, SIUU).

·      Support additional promotional-compliance-related activities as mutually agreed.

Qualifications:

·      10+ years of hands-on experience in Regulatory Advertising and Promotional Review in the pharmaceutical or biotechnology industry

·      Strong familiarity with FDA regulations and guidance related to advertising and promotion

·      Specific experience with CFL guidance is required.

·      Experience with newer SIUU guidance is preferred.

·      Prior experience in CNS or nephrology therapeutic areas preferred

·      Prior experience with Veeva Vaults Promo mats is highly preferred

Required Skills:

·      Ability to articulate regulatory rationale in both written and verbal formats

·      Deep understanding of how to evaluate promotional claims consistent with clinical data and labeling

·      Solid knowledge of clinical trial design and statistical principles sufficient to interpret efficacy and safety data

Term & Start

·      6-month contract, possible extension (15-25 hours per week hours/week)

·      2 Video Interviews - Start 2-3 weeks from an offer

·      Remote – EST hours preferred