Project Manager III #21-03015
• 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.
• Will be responsible for certifying material compliance to the FDA on behalf of client, and as such it is imperative, they have adequate experience and background to perform that role.
• Serve as FDA liaison for matters related to the advertising and promotion of assigned products
• 7 years in Regulatory ad/promo experience.
• Must have Quality experience
• Seeking candidates that require minimal oversight.
**Must have advertising and promotional review experience.