Regulatory Advertising and Promotional Review Consultant

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Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Regulatory 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

· Sales training materials

· Disease awareness and unbranded campaigns

· 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

• 15-25 hours per week hours/week - must be available to consult on Tuesdays and Thursdays
• 2 Video Interviews - Start 2-3 weeks from an offer
• Remote – EST hours preferred

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Part-time

• Job function
  
  Research, Science, and Public Relations
• Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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