Principal Medical Writer – GenAI, Regulatory Writing Innovation

Job Description: • 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. Requirements: • 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. Benefits: • 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 Apply tot his job Apply To this Job