Dir Regulatory Advertising & Promo Review-2372131 Job Details

The Director Regulatory Advertising & Promotional Review will provide regulatory guidance on advertising and promotional materials and activities to ensure the company implements product advertising and marketing programs consistent with good science, applicable laws and regulations, the company's code of conduct and policies, and prudent risk management. This is a unique opportunity to build the regulatory advertising and promotion function in a dynamic, young company. This position will report to the Senior Director, Regulatory Affairs.
In this position you will provide regulatory direction and risk evaluation to support the creation of compliant and competitive promotional materials and practices, develop Regulatory Affairs policies and procedures for review and approval of product promotional material. Review, approve, and monitor product advertising and promotional materials as well as Medical Affairs and Corporate Communication practices to ensure compliance with laws and regulations, best industry practices, and the company's policies/code of conduct. Establish robust cross-functional training programs that are fully compliant with FDA regulations/guidance, PhRMA guidelines, company policy, and business goals. Monitor U.S. regulatory climate by reviewing DDMAC letters and regulatory guidelines, and provide guidance and direction to the company on changes in this area. Maintain working knowledge of company products, review and approve presentations developed by the Commercial and Medical Affairs departments for use in obtaining expert advice from the companys advisor consultants. Provide effective and appropriate recommendations for Phase 4 clinical trial design with regard to promotability of potential data/claims.

B.S./B.A. degree in pharmacy, pharmacology, or other life sciences (M.S./Pharm.D. preferred) with a minimum of 10 years of pharmaceutical industry experience, at least eight years in a regulatory function, and at least three years in review and approval of product promotional material. In-depth knowledge of PhRMA Code as well as laws, regulations, and guidance regarding promotion of pharmaceutical products. Knowledge of key enforcement activities and ability to assess the changing regulatory environment. Demonstrated ability to communicate with DDMAC to establish a shared view of the label, its interpretation and appropriate features and benefits necessary for the physicians to effectively manage patients. Strong written, verbal, and interpersonal skills, along with the ability to evaluate and articulate regulatory risk, establish and maintain effective relationships, influence others in a positive and effective manner, and work collaboratively with Marketing, Sales, Medical, Legal, and R&D. The Ability to analyze and interpret efficacy and safety data also the ability to relate information presented in advertising and promotional materials to regulatory requirements and to identify inconsistencies, as well as to proofread and check documents for accuracy.

Contact:
Sharon Davis, Account Manager Regulatory Affairs, The Cambridge Group a part of On Assignment Clinical Research, 800-525-3396 x15802, 203-226-4243, sharon.davis@onassignment.com