Principal Medical Writer – GenAI and Regulatory Writing Innovation
BiogenThis 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.
Coding experience is not required, but a strong curiosity and comfort with GenAI tools (e.g., ChatGPT, Claude, Gemini, Copilot, etc.)—and an ability to apply them in daily work—will be key to success.
What You’ll Do
- 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.
Who You Are
You are an experienced regulatory writer who combines deep scientific and communication expertise with an innovative mindset. You are eager to explore how AI can transform regulatory writing and are comfortable experimenting with new technologies to improve workflows. You excel in cross-functional collaboration, balance strategic thinking with hands-on writing, and are passionate about quality, compliance, and innovation.
Required Skills
- 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.
Preferred Skills
- 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.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.