**Fully Remote Opportunity
- Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
- Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.
- Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials
- Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.
- Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
- Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
- Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
- Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
- 5+ years experience in advertising/promotion review
- Experience as FDA liaison for issues relating to promotional material
- Ability to review material for compliance with federal regulations and guidelines and corporate policy with little oversight
- Ability to learn new products and quickly
- Demonstrated ability to work collaboratively with legal, medical, and commercial
- *Preferred, but not required: experience with diabetes/metabolism products.
- This role will be fully remote