Principal Medical Writer - GenAI and Regulatory Writing Innovation

This is a remote-based position, candidate must be located within the USA

About This Role

The Principal Medical Writer serves as a scientific communication and innovation leader within Biogen's Medical Writing department, focusing on leveraging Generative AI (GenAI) technologies to transform regulatory writing. In this role, you will combine your expertise in regulatory document strategy with forward-looking approaches to content generation, automation, and AI-enabled writing support.

You will author and oversee preparation of high-quality clinical regulatory documents (e.g., clinical summaries, CTAs, INDs, and briefing packages) and collaborate closely with cross-functional teams to ensure clarity, accuracy, and consistency. Additionally, you will work on collaborative initiatives with internal and external partners to develop and pilot GenAI tools that enhance efficiency, quality, and compliance in medical writing workflows.

• Provide medical writing leadership and authoring expertise for assigned program(s), ensuring timely delivery of regulatory and clinical documents of the highest quality.
• Lead or contribute to innovation projects applying GenAI to automate and optimize regulatory writing processes in collaboration with internal stakeholders (e.g., Data Science, Regulatory, and Clinical teams) and external partners.
• Serve as a GenAI champion within the Medical Writing function-sharing best practices, identifying use cases, and promoting responsible adoption of AI-enabled tools.
• Provide strategic input and writing support for major submission documents such as Clinical Overviews, Summaries, and regulatory briefing packages.
• Mentor and guide junior writers, providing oversight and feedback on content, timelines, and quality expectations.
• Support the development of GenAI training materials and process enhancements to upskill the medical writing team.
• Contribute to departmental initiatives that foster innovation, efficiency, and continuous improvement.
• Ensure consistency of scientific messaging and alignment with therapeutic area strategy across documents.

• Bachelor's degree in Life Sciences or a health-related discipline required; advanced degree (MS, PhD, PharmD, MD) preferred.
• At least 7 years of experience in the biopharmaceutical industry (advanced degree or academic research may substitute for some experience).
• Minimum 5 years of hands-on medical writing experience supporting clinical regulatory submissions (e.g., CTD, IND, NDA/BLA components).
• Demonstrated expertise in therapeutic area document requirements and global regulatory standards.
• Familiarity with large language models (LLMs) and GenAI applications for writing, summarization, or data interpretation.
• Proven ability to manage multiple complex deliverables, work effectively in a matrixed team, and mentor others.
• Excellent written and verbal communication skills, with meticulous attention to scientific and regulatory accuracy.

• Experience or strong interest in applying GenAI tools for writing, document review, or data summarization.
• Ability to translate AI capabilities into practical solutions within regulated environments.
• Understanding of ethical and compliance considerations for AI use in scientific communication.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation