PRC Medical Reviewer IV Position Available In Mercer, New Jersey

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.