Principal Medical Writer – Genai And Regulatory Writing Innovation

Biogen

Remote, , USA
Base: $132,000.00-$176,000.00; bonus/equity: cash ...
Fully remote
Regulatory medical writing expertise
Generative ai tools experience
Clinical regulatory submissions knowledge
The Principal Medical Writer will lead and innovate in regulatory writing by leveraging Generative AI technologies to enhance efficiency, quality, and compliance

Job Summary

  • The Principal Medical Writer will lead and innovate in regulatory writing by leveraging Generative AI technologies to enhance efficiency, quality, and compliance.
  • Biogen offers a comprehensive benefits package including medical, dental, vision, life insurance, paid vacation, holidays, parental leave, 401(k) with company match, and tuition reimbursement.
  • The company fosters a culture of inclusion, belonging, and continuous learning, emphasizing diversity and employee empowerment.

Matching Summary

The Principal Medical Writer will lead and innovate in regulatory writing by leveraging Generative AI technologies to enhance efficiency, quality, and compliance.

Salary

Base: $132,000.00-$176,000.00; Bonus/Equity: Cash bonus and equity incentives available; Benefits: Comprehensive medical, dental, vision, life insurance, paid time off, 401(k), tuition reimbursement

Skills & Requirements

Must-have

  • Regulatory medical writing expertise
  • Generative AI tools experience
  • Clinical regulatory submissions knowledge
  • Cross-functional collaboration skills
  • Mentoring junior writers
  • Scientific communication leadership

Nice-to-have

  • Innovation and process improvement mindset
  • Ethical AI use understanding
  • Training material development
  • Quality and compliance focus
  • Strategic thinking and hands-on writing balance

Key Requirements

  • Bachelor’s degree in Life Sciences or health-related field
  • Minimum 7 years biopharmaceutical industry experience
  • At least 5 years medical writing for clinical regulatory submissions
  • Familiarity with global regulatory standards
  • US-based remote work requirement

Work Rights

Must be located within the USA

Tailored Resume

Cover Letter