PRC Regulatory Advertising and Promotion Reviewer
Advanced Clinical, Princeton, NJ, United States
Expected range/hours per week: 20-40hours
May increase toward 40 hours during peak promotional period
Key Responsibilities
Participate in cross-functional Promotional Review Committee (PRC) meetings as the regulatory reviewer for promotional materials.
Evaluate marketing and promotional content to ensure alignment with approved labeling, supporting clinical data, FDA regulations, and internal compliance standards.
Apply knowledge of FDA advertising and promotional guidance, including CFL and SIUU, during the review process.
Provide regulatory support for promotional materials related to products approved under the Accelerated Approval pathway.
Support additional promotional compliance and regulatory review activities as needed.
Minimum Qualifications
10+ years of experience in Regulatory Advertising and Promotional Review within the pharmaceutical or biotechnology industry.
Strong knowledge of FDA advertising and promotion regulations and guidance.
Experience applying CFL guidance; familiarity with SIUU guidance preferred.
Experience supporting promotional review for Accelerated Approval biologic products strongly preferred.
Therapeutic area experience in CNS or nephrology preferred.
Experience with Veeva Vault PromoMats highly preferred.
Key Skills
Ability to communicate clear regulatory rationale in written and verbal formats.
Strong ability to evaluate promotional claims against clinical data and labeling.
Understanding of clinical trial design and statistical interpretation.
Comfortable working in fast-paced, cross-functional environments and managing high volumes of promotional review work.
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May increase toward 40 hours during peak promotional period
Key Responsibilities
Participate in cross-functional Promotional Review Committee (PRC) meetings as the regulatory reviewer for promotional materials.
Evaluate marketing and promotional content to ensure alignment with approved labeling, supporting clinical data, FDA regulations, and internal compliance standards.
Apply knowledge of FDA advertising and promotional guidance, including CFL and SIUU, during the review process.
Provide regulatory support for promotional materials related to products approved under the Accelerated Approval pathway.
Support additional promotional compliance and regulatory review activities as needed.
Minimum Qualifications
10+ years of experience in Regulatory Advertising and Promotional Review within the pharmaceutical or biotechnology industry.
Strong knowledge of FDA advertising and promotion regulations and guidance.
Experience applying CFL guidance; familiarity with SIUU guidance preferred.
Experience supporting promotional review for Accelerated Approval biologic products strongly preferred.
Therapeutic area experience in CNS or nephrology preferred.
Experience with Veeva Vault PromoMats highly preferred.
Key Skills
Ability to communicate clear regulatory rationale in written and verbal formats.
Strong ability to evaluate promotional claims against clinical data and labeling.
Understanding of clinical trial design and statistical interpretation.
Comfortable working in fast-paced, cross-functional environments and managing high volumes of promotional review work.
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