[Remote] Regulatory Advertising and Promotional Review Consultant

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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