The Sr. Manager/Associate Director, under the direction of the Head of Regulatory Product Communications within Commercial Regulatory Affairs, will be responsible for regulatory strategy and operational leadership in the area of product and disease state communication for one or more Vertex products and development programs. This individual will be primarily responsible for ensuring that product and disease state communications meet the needs of the organization and are in compliance with applicable laws, regulations and guidelines in the U.S. In addition this individual will also support global reviews of product or disease state communications. This seasoned regulatory professional will contribute to the ongoing development of a best in class commercial regulatory function within Global Regulatory Affairs, with responsibility for the review of communications for North America and for Global Commercial and Medical Affairs.
Collaborates cross functionally with regional and global key stakeholders in areas such as Marketing, Medical Affairs, and Legal
- Creatively advises on the development of product and disease state communication materials across multiple functional areas: including Corporate Communications, Health Economics and Outcomes Research, and Medical Affairs.
- Reviews and approves product and disease state communications to support corporate goals and comply with applicable laws, regulations, and guidance in the U.S.
- Chairs one or more internal multidisciplinary committees charged with the review and approval of product and disease state materials, as well as overseeing the submission of those materials to health authorities as needed.
- Provides training to key stakeholders on laws and regulations related to drug advertising and promotion.
- Works closely with the Global Labeling Head to evaluate and advise on promotional applicability of information in labels for compounds under development
- Serves as the primary contact with the FDA Office of Prescription drug Promotion (OPDP) for assigned products
· Must have a minimum of 5 years of experience within regulatory affairs, reviewing promotional materials, interacting with OPDP, and managing launch campaigns
· Expert knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
· Proven ability to influence cross-functional teams and work effectively with senior management
· Excellent written and verbal communication skills
· Advanced degree (i.e.: Masters, PharmD) is preferred Familiarity with labeling regulations and global promotion review experience a plus