PRC Regulatory Advertising & Promotion Reviewer IV - #26-20980

Duration:12 months
Description:

PRC Advertising & Promotion Reviewer tasks include:

• Provide 20-40 hours per week as business needs dictate of regulatory affairs advertising and promotional review of products.
• 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 promotional review for products approved under Accelerated Approval (Subpart H).
• Support additional promotional-compliance-related activities as mutually agreed.

Minimum 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.
• Direct experience supporting promotional review for products approved under Accelerated Approval products for Biologics, is strongly 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.
• Collaborative and solution-oriented team player who contributes positively to cross-functional discussions.
• Comfortable working in a fast-paced, matrixed environment with cross-functional business partners.
• Ability to manage high-volume promotional review needs in support of ongoing commercial activities including shifting priorities and time-sensitive business deliverables.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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