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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