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
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