Biogen

Principal - Medical Writing

Biogen

225 Binney St, Cambridge, MA 02142, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

Independently prepares complex clinical documents; independently coordinates preparation of clinical documents for regulatory submissions and/or publication strategies for one or more programs Represents department on clinical teams (e.g. SMT, CDT); leads document-related meetings; reviews statistical analysis plans and clinical data reports to ensure consistent data reporting within a program and/or therapeutic area. Mentors junior writers on departmental processes related to document preparation (e.g., planning document-related meetings, developing document timelines); reviews documents written by junior writers for content and format; coordinates work of multiple writers contributing to a regulatory submission or publication strategy. Leads departmental initiatives; represents department on interdepartmental initiatives.

Where is this job?
This job is located at 225 Binney St, Cambridge, MA 02142, USA
Job Qualifications
  • 7+ yrs regulatory writing experience

  • PhD is a plus

  • Strong understanding of internal and external guidelines related to document preparation.

  • Ability to analyze data and make recommendations for consistent data reporting standards. Strong understanding of standard clinical document types.

Required Skills
  • Documentation

  • Data Analysis

  • Time Management

  • Presentation skills

Soft Skills
  • Communication

  • Multitasking

  • Process Improvement

  • Detail Oriented

  • Strategic planner

Compensation

According to JobzMall, the average salary range for a Principal - Medical Writing in 225 Binney St, Cambridge, MA 02142, USA is $105,000 to $135,000 per year.

Additional Information
Biogen is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedSeptember 8th, 2020
Apply BeforeMay 22nd, 2025
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About Biogen

Biogen, Inc. is a global biotechnology company, which focuses on discovering, developing, manufacturing and delivering therapies for neurological, autoimmune and hematologic disorders.

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