Regulatory Affairs/Safety and Benefit-Risk Management Fellowship
Global Medical Fellowship
Regulatory Affairs-Advertising, Labeling, and Promotion Fellowship
Medical and Value Based Outcomes Fellowship
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 Development, 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)
- Global Labeling
- Clinical Trial Applications (CTA)
- R&D Compliance
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
The fellow will have the opportunity to spend up to four months in another department within Biogen Idec. Departments may include but are not limited to:
- Clinical Drug Supply Chain
- Global Clinical Operations
- Global Commercial Strategy
- Health Economics and Outcomes Research
Priya Singhal, MD, MPH
Vice President, Global Head
Safety and Benefit-Risk Management
"In the innovative and ever-changing world of drug safety and risk management, we are committed to providing challenging experiences that build a depth of knowledge and foster the potential for accelerated professional development."
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 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
- Medical Information & Congress
- Medical Training
- Medical Planning & Operations
- Medical Writing
- Medical Education and Grants
- Medical Director’s Office
- Medical Publications
- Clinical Research
- Medical and Value Based Outcomes
- Insights and Analytics
The fellow will have the opportunity to spend up to three months in another department within Biogen Idec. Departments may include but are not limited to:*
- Global Marketing
- Safety and Benefit-Risk Management
- Regulatory – Development
- Global Market Access
*All options subject to availability. Additional options may be available depending upon interest.
Amit Rakhit, MD
Senior Vice President, Global Medical
Safety and Benefit-Risk Management
"The Global Medical Fellowship provides fellows the opportunity to expand their horizons; it challenges them to learn new concepts in the research, development, and commercial areas and fosters growth of the leadership competencies needed for the dynamic biopharmaceutical landscape"
Regulatory Affairs- Advertising, Labeling, & Promotion (ALP)
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 develops 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 skills cannot be obtained solely from a professional degree; instead, the necessary knowledge is extensively gained predominantly through on-the-job training and hands-on experience. Biogen Idec recognizes this critical need for experienced Regulatory—ALP 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, labeling, 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 Regulatory ALP 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 ALP.
Medical and Value Based Outcomes
Biogen Idec’s Medical and Value Based Outcomes (MVBO) team establishes and fosters ongoing professional relationships with key managed market decision/policy makers to provide comprehensive medical education, collaborative research opportunities, and comparative effectiveness health outcomes solutions that seek to improve patient care within a cost-conscious and evolving healthcare environment.
During the first year of the fellowship, the fellow will obtain a working functional knowledge within the core groups with which MVBO partners. The fellow will also have an opportunity to choose a rotation outside of the core curriculum to enhance his or her experience and understanding of the biopharmaceutical industry.
The second year of the fellowship is dedicated to gaining an advanced experience within the MVBO team. The fellow will complete various research initiatives, present at congresses, partake in field rides with our Medical Outcomes Science Liaison team, and consistently work to be a trusted partner within the team.
The fellow will have the opportunity to spend up to three months in another department within Biogen Idec. Departments may include but are not limited to:
- Health & Economics Outcomes Research
- Value Based Medicine
- Pricing & Channel Distribution
- Patient Services
- US Medical Director’s Office
- Government Policy & Advocacy
- Global Market Access (GMAx)
- Global Medical