Regulatory Affairs and Safety and Benefit-Risk Management
Regulatory Affairs is a well-integrated global department that provides worldwide strategic regulatory guidance and operational support for Biogen Idec's development and commercial programs. The fellow will acquire a better understanding of the dynamics of the drug development process throughout the life cycle of our products, from early development through approval and commercialization.
During the rotation in Regulatory Affairs, the fellow will have the opportunity to gain experience in the different functional groups of the regulatory department:
- Chemistry, Manufacturing, and Controls (CMC)
- Advertising, Labeling, and Promotion (ALP)
- Regulatory Operations
- Regulatory Global Labeling (RGL)
- R&D Compliance
- Regulatory Intelligence
Safety and Benefit-Risk Management (SABR)
Biogen Idec is responsible for the continuous assessment of the benefit-risk relationship of all of its products starting in the early stages of development and throughout the post-marketing phase. Members of the Safety and Benefit-Risk Management department are continuously working to gain better understanding of the safety profile of marketed products as well as those in development in order to provide the medical community and patients with the necessary data to make an informed decision regarding disease management.
During the rotation in SABR, the fellow will have an opportunity to rotate through three general areas:
- Global Case Management
- Pharmacovigilance (PV) Scientists
Carmen Bozic, M.D.
Senior Vice President, Global Head
Safety and Benefit-Risk Management
"Our commitment is to educate our fellows on the complex, rapidly evolving world of biopharmaceutical drug safety and risk management and to provide them with the necessary tools to help them shape their own careers."
Global Medical Affairs
Biogen Idec’s Global Medical Affairs department has a mission to improve patient outcomes by bringing the best expertise to our customers and enabling our company to be the most-trusted company in MS. We do this by providing support to Research and Development and Global Commercial Operations, as well as being responsible for clinical development and research, medical publications, biostatistics, medical education and many other services. Global Medical Affairs is also responsible for providing health care professionals, regulatory agencies and professional groups the medical and scientific information they need to understand our company’s products.
During the first year of the fellowship program, the fellow will have the opportunity to explore the many different functional areas within Medical Affairs. If desired, the fellow will have the opportunity to select a rotation outside of Medical Affairs for greater experience and understanding of the biopharmaceutical industry. For the second year of the fellowship, the fellow will pick an area of concentration to prepare them for a career within the pharmaceutical industry. The area of concentration must be within Global Medical Affairs. Potential functional group rotations include:
- Medical Communications & Training
- Medical Information
- Medical Planning & Operations
- Medical Research
- Medical Education and Grants
- Medical Director’s Office
- Medical Market Access
- Options outside GMA (limited to 1 rotation)
- Global Marketing
- Safety and Benefit-Risk Management
- Regulatory Affairs
Glenn Pierce, M.D., Ph.D.
Senior Vice President
Global Medical Affairs
"The landscape of the biopharmaceutical industry is constantly evolving and our global medical affairs fellowship provides fellows with unique leadership and development opportunities to shape prosperous careers within the industry."
Regulatory Affairs–Advertising, Labeling, and Promotion Fellowship
Regulatory Affairs Advertising, Labeling, and Promotion (ALP) is one of the functional groups within the Regulatory Affairs organization that supports Biogen Idec's development and commercial programs.
The Regulatory Affairs ALP team is responsible for providing Biogen Idec 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. In addition, this team is responsible for the creation, revision, and maintenance of U.S. product labeling. The ALP group leads communications with regulatory agencies related to U.S. labeling, advertising, and promotion.
This two-year Regulatory Affairs –ALP fellowship is designed to provide advanced hands-on experience and develop Regulatory-ALP professionals with comprehensive knowledge of advertising and labeling regulations and real-world applications to the development of product labels and the oversight of promotional material from the biopharmaceutical perspective.
Regulatory Affairs-ALP is an area in which vital skills cannot be learned directly from solely a professional degree; rather, it requires on-the-job training and insight gained from experience. Biogen Idec recognizes this critical need for experienced professionals in Regulatory-ALP and has partnered with Marketing department to offer a fellowship with opportunities to:
- Learn FDA regulations that govern Advertising, Labeling, and Promotion
- Accurately and effectively apply regulations and provide sound guidance
- Learn Marketing's role in promotional material development, from inception to final execution
The overall goal of the program is to prepare each fellow to be a successful Regulatory ALP professional with a solid understanding of how FDA regulations are followed by the biopharmaceutical industry and enforced by FDA. Upon completion of the fellowship, the experienced fellow will be well-prepared to begin a career in Regulatory ALP.
*All options subject to availability. Additional options may be available depending upon interest.