Job Description
Note: The job is a remote job and is open to candidates in USA. GForce Life Sciences is engaged by a growing, mid-sized pharmaceutical client to provide a Regulatory Advertising and Promotional Reviewer. The role involves conducting thorough regulatory reviews of promotional materials for compliance with FDA regulations and participating in promotional review committees.
- Responsibilities
- 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
- Skills
- 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
- 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
- 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
- Company Overview
- GForce Life Sciences is a platform for career management that offers executive search, medical affairs consulting, and project management. It was founded in 2013, and is headquartered in Chicago, Illinois, USA, with a workforce of 51-200 employees. Its website is https://www.gforcelifesciences.com.
- Company H1B Sponsorship
- GForce Life Sciences has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2024, 1 in 2023, 1 in 2022. Please note that this does not guarantee sponsorship for this specific role.
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