Programs

Biogen Idec Fellowship in Drug Safety and Regulatory Affairs

Worcester

Biogen Idec, Inc., in collaboration with the Massachusetts College of Pharmacy and Health Sciences (MCPHS) in Worcester offers a unique two-year fellowship program to promote the role of the Doctor of Pharmacy within the biopharmaceutical industry. The fellow will gain extensive experience through various practical activities in both industrial and academic settings, which will enhance the potential for accelerated career development.

Fellowship overview

This fellowship program is designed to offer Doctor of Pharmacy graduates in-depth experience in Drug Safety and Regulatory Affairs within a biopharmaceutical industry setting. In addition, PharmD graduates will have the opportunity to enhance their clinical and academic background in conjunction with the Massachusetts College of Pharmacy and Health Sciences in Worcester. Overall, this fellowship program will provide the training and experiences necessary to prepare the fellow for a career in the competitive pharmaceutical industry.

Biogen Idec, Inc., a global biotechnology leader with leading products and capabilities in oncology, neurology and immunology, is committed to transforming scientific discovery into advances in healthcare. The company's core capabilities include drug discovery, research, development, biomanufacturing, and a global commercial infrastructure. Biogen Idec pursues the creativity of science with passion and discipline. For more than 25 years, the company has grown through the discovery, development and commercialization of its own innovative products and through strategic alliances.

Scientific excellence that achieves new standards of care drives the company's work. With four commercial products and seventeen products currently in clinical development, Biogen Idec is addressing a variety of key medical needs. In addition to Biogen Idec's promising portfolio of drug candidates, the company's capabilities and capacity for protein manufacturing are world-class in quality and scale. The company is one of a handful of biotechnology companies that has three licensed and dedicated biological bulk-manufacturing facilities, including its large-scale manufacturing plant in Research Triangle Park, NC, which is one of the world's largest cell culture facilities. An additional large-scale manufacturing plant is under construction in Hillerød, Denmark. Biogen Idec has sufficient commercial manufacturing capacity for its own pipeline, as well as potential partners' products.

Biogen Idec is headquartered in Cambridge, MA and was formed from the merger of two of the world's leading biotechnology companies, Biogen, Inc., founded in Switzerland in 1978, and IDEC Pharmaceuticals Corporation, founded in San Francisco, CA in 1985. The company maintains research centers of excellence in San Diego, CA and Cambridge, MA. Biogen Idec has additional offices in Canada, Australia, Japan and throughout Europe, including international headquarters in Zug, Switzerland and operates a global distribution network, which covers over 70 countries. The company currently employs approximately 3,400 people worldwide.

The Biogen Idec fellowship program will be offered at the headquarters in Cambridge, MA and will include main two components; Regulatory Affairs and Drug Safety/Risk Management. The fellow will spend ten months as a member of the Regulatory Affairs team, four months of elective time which can be spent in other areas in the company of interest to the fellow or completing a clinical rotation at a teaching hospital, and the remaining ten months of the second year as a member of the Drug Safety/Risk Management team.

Regulatory Affairs:

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 rotate 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.

Drug Safety & Risk Management:

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 postmarketing 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 may 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

Massachusetts College of Pharmacy and Health Sciences

The Biogen Idec fellow will have the opportunity to:

  • Develop, coordinate, and teach courses at the Worcester campus
  • Attend monthly seminars at the Worcester campus with other fellows/residents
  • Publish review articles
  • Present poster(s) at professional meeting

Elective Options

The fellow will have the option of spending up to four months in another area within the company or completing a clinical rotation at a teaching hospital.
*Other areas within Biogen Idec may include:

  • Medical Information
  • Clinical Research
  • Medical Affairs
  • Marketing
In addition, the fellow will have the opportunity to precept PharmD students at Biogen Idec.
*All options subject to availability



Program Design

Duration: Two Years
Number of positions: Two
Start Date: July 1
Compensation: The fellow will receive a competitive stipend and benefit package, including comprehensive health insurance. Attendance to one or more professional meetings, conferences or workshops will be sponsored by Biogen Idec.


Certificate of Completion

MCPHS and Biogen Idec will award a certificate upon successful completion of the fellowship program.


Program Directors

Biogen Idec:

  • Stacie Knight, Mehdi Chakir, PharmD
MCPHS:
  • Courtney Jarvis, PharmD, Michael Steinberg, PharmD


Eligibility

  • The Biogen Idec fellow will be selected on a nationally competitive basis.
  • Applicants must hold a Doctor of Pharmacy degree from an ACPE – accredited college of pharmacy at the commencement of the program.
  • Candidates must have excellent written/verbal communication skills and a strong interest in pursuing a career within the biopharmaceutical industry.

Application Procedure

  • Interested individuals are invited to electronically submit their letter of intent, curriculum vitae, and three letters of recommendation to fellowship@biogenidec.com.
  • Mail official transcript(s) to:
    Stacie Knight, Regulatory Affairs 14 Cambridge Center Cambridge, MA 02142
  • Interested candidates should submit their application materials starting from Nov 15th through Jan 2nd.