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Biogen Idec is hiring: Senior Medical Writer in Cambridge

Biogen Idec
Cambridge, MA Full Time
POSTED ON 2/25/2025 CLOSED ON 5/20/2025

What are the responsibilities and job description for the Biogen Idec is hiring: Senior Medical Writer in Cambridge position at Biogen Idec?

Job Description

About This Role

As our new Senior Medical Writer you will provide medical writing support for clinical and regulatory documents. You will interact with other medical writers, document quality reviewers, and cross-functional teams as you create, author, and manage documentation required for the conduct of clinical trials and regulatory submissions.

A successful candidate will participate in cross-functional teams, and may lead strategy discussions related to document development and influence decision making.

What You'll Do

  • Independently prepare moderately complex clinical documents for one or more programs
  • Coordinate preparation of clinical documents by other writers with minimal supervision
  • Represent the Medical Writing department on cross-function teams
  • Lead document-related meetings
  • Review statistical analysis plans and clinical data reports, as needed
  • Mentor junior writers on department processes related to document preparation
  • Participate on departmental initiatives

Qualifications

Required Skills

  • Master's required in a life science or health discipline
  • 1 years regulatory writing experience within a life science organization
  • Ability to interpret data
  • Solid understanding of standard clinical document types
  • Solid understanding of internal and external guidelines related to document preparation
  • Strong written and oral communication skills
  • Strong organizational and meeting skills
  • Preferred Skills

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