Core Rotations: Overview

Regulatory Affairs is a well-integrated global organization 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. The Fellow will acquire this experience through the different functional groups of the regulatory department:

• Development
• Chemistry, Manufacturing, and Controls
• Advertising, Labeling, and Promotion
• Regulatory Operations/Compliance
• The Fellow will receive guidance from regulatory managers and interact with project teams, and regulatory bodies, as appropriate.

Biogen Idec is responsible for the continuous assessment of the Benefit-Risk relationship on all of its products from the early stages of development and throughout the post-marketing phase. The Drug Safety and Risk Management department works closely with the medical community as well as with the patients through a variety of monitoring programs to collect, monitor, investigate and report adverse events. Activities in which the Fellow will be involved include:

• Adverse event collection, evaluation, classification and reportability
• Completion of individual case report narratives
• Performance of in-depth analysis for adverse events of interest
• Preparation of Periodic Safety Update Reports (PSUR)
• Ongoing safety monitoring of Biogen Idec products including signal identification and evaluation

The Biogen Idec Fellow will have the opportunity to:

• Teach
• Develop and coordinate classes at MCPHS, Worcester
• Attend/present at monthly seminars with other MCPHS fellows/residents
• Publish review articles
• Elective rotations

The Fellow will have the option of spending up to 4 months in another area within the company or completing a clinical rotation at a teaching hospital.

Other areas within Biogen may include:

• Program Alliance Management
• Medical Information
• Clinical Research
• Medical Affairs
• Marketing