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
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• 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