21 days ago
- Serve as Regulatory Reviewer on Commercial and Medical Review Boards for assigned product(s)
- Provides regulatory guidance in the development and approval of compliant advertising and promotional materials.
- Advise on clinical study design and labeling to support desired commercial claims
- Act as lead at review metings by leading discussion and collaborating with other reviewers to determine next steps and approval status.
- Act as expert on FDA regulations governing the promotion of prescription pharmaceutical products.
- Obtains understanding of OPDP requirements as well as undesratnding of enforcement trends.
- Performs detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved labeling and delivers consistent, well-supported, and clear guidance.
- BA/BS degree and 6+ years of relevant experience, including 2-4 years of experience in the regulatory review of promotional materials for prescription drug and/or biologic products.