Regulatory Sciences - Advertising and Promotion (AP) is one of the functional groups within the Regulatory Sciences organization that support Biogen’s development and commercial programs. The Regulatory Sciences - AP team is responsible for providing Biogen with strategic, high-quality, timely, and decisive regulatory advice on advertising and promotional materials, communications, and company activities in accordance with FDA regulations, company policies, and business goals. The AP group leads communications with regulatory agencies related to US advertising and promotion. This 2-year fellowship is designed to provide advanced hands-on experience. The fellowship develops professionals with comprehensive knowledge of advertising regulations and real-world applications for promotional material from the biopharmaceutical perspective.

Regulatory Sciences - AP is an area in which skills cannot be obtained solely from a professional degree; instead, the necessary knowledge is gained predominantly through on-the-job training and hands-on experience. Biogen recognizes this critical need for experienced Regulatory Sciences - AP professionals and has partnered with the marketing department to offer a fellowship with opportunities to experience and learn the following:

• The FDA regulations that govern advertising and promotion
• How to accurately and effectively apply regulations and provide guidance
• How promotional materials are developed through the commercial organization

The overall goal of the program is to prepare each fellow to be a successful AP professional with a solid understanding of how FDA regulations are followed by the biopharmaceutical industry and enforced by the FDA. Upon completion of the fellowship, the experienced fellow will be well-prepared to enter into an advanced career in Regulatory Sciences - AP.

View the Biogen Program Brochure for more information, or visit http://www.mcphs.edu/pharmdfellow for general fellowship program information.