Job Description

Job Title: PRC Medical Reviewer IV

Location: Princeton, NJ

Job Responsibilities:

• Conduct comprehensive regulatory reviews of promotional material to ensure compliance with FDA advertising and promotion regulations. This includes healthcare professional materials, direct-to-consumer campaigns, sales training materials, disease awareness and unbranded campaigns, and corporate materials.
• Participate in cross-functional promotional review committees as the Promotion Compliance/Regulatory Advertising and Promotional reviewer.
• Ensure promotional claims align with approved labeling, are supported by data, comply with regulations, and are consistent with company policy.
• Stay updated on evolving FDA guidance and apply this knowledge to ongoing review work.
• Support additional promotional-compliance-related activities as agreed.

Skills Required:

• 10+ years of hands-on experience in Regulatory Advertising and Promotional Review in the pharmaceutical or biotech industry.
• Strong familiarity with FDA regulations and guidance related to advertising and promotion.
• Specific experience with CFL guidance is required, and experience with newer SIUU guidance is preferred.
• Prior experience in CNS or nephrology therapeutic areas is preferred.
• Prior experience with Veeva Vaults Promo mats is highly preferred.
• 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.

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