Senior Specialist, Nonclinical Medical Writing
Merck
August 24, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Key Responsibilities:
- Coordinate generation of preclinical reports and regulatory submission modules; manage scope/timelines and guide internal review/approval and submission in collaboration with research and regulatory teams.
- Perform preclinical data collection and QC to ensure regulatory-compliant data integrity.
- Analyze/synthesize nonclinical datasets and develop scientific narratives integrating pharmacology, efficacy, and translational findings; ensure document consistency.
- Author, edit, format, and submit pharmacology study reports, integrated pharmacology summaries, and other regulatory documents to internal documentation/filing systems.
- Ensure documents meet scientific, regulatory, and quality standards and comply with guidance and document management practices.
- Develop writing templates, best practices, guidelines, and standards.
- Evaluate/adopt new digital and AI tools to improve scientific writing efficiency, quality, and scalability.
- Support document QC and transfer for business development & licensing activities with internal/external partners.
Qualifications:
- Education: Bachelor’s (7+ years), Master’s (4+ years), or Ph.D. (1+ year) in biology, pharmacology, or related field with medical writing and regulatory submission experience in pharma/biotech.
Required Experience & Skills:
- Knowledge of nonclinical regulatory filing modules (CTD, IND, CTA, IMPD, NDA/BLA/MAA).
- Strong scientific writing/editing for study reports, IB, CTD Module 2 nonclinical summaries, and related documents.
- Understanding of drug discovery/development, pharmacology, and in vitro/in vivo lab operations.
- Hands-on experience supporting nonclinical drug discovery and early development.
- Strong project management; ability to balance competing priorities and timelines.
- Proficiency with Microsoft Office, data graphing/visualization tools, and document management software.
- Strategic/analytical thinking; clear written/verbal communication; strong attention to detail.
Preferred:
- Experience in therapeutic areas (e.g., oncology, neuroscience, immunology, cardiovascular-metabolic, infectious diseases).
- Knowledge of therapeutic modalities (small molecules, biologics, drug conjugates) and/or vaccines.
- Experience with AI-enabled data retrieval, QC, and scientific writing tools.
- AMWA certificate.
- Coordinate generation of preclinical reports and regulatory submission modules; manage scope/timelines and guide internal review/approval and submission in collaboration with research and regulatory teams.
- Perform preclinical data collection and QC to ensure regulatory-compliant data integrity.
- Analyze/synthesize nonclinical datasets and develop scientific narratives integrating pharmacology, efficacy, and translational findings; ensure document consistency.
- Author, edit, format, and submit pharmacology study reports, integrated pharmacology summaries, and other regulatory documents to internal documentation/filing systems.
- Ensure documents meet scientific, regulatory, and quality standards and comply with guidance and document management practices.
- Develop writing templates, best practices, guidelines, and standards.
- Evaluate/adopt new digital and AI tools to improve scientific writing efficiency, quality, and scalability.
- Support document QC and transfer for business development & licensing activities with internal/external partners.
Qualifications:
- Education: Bachelor’s (7+ years), Master’s (4+ years), or Ph.D. (1+ year) in biology, pharmacology, or related field with medical writing and regulatory submission experience in pharma/biotech.
Required Experience & Skills:
- Knowledge of nonclinical regulatory filing modules (CTD, IND, CTA, IMPD, NDA/BLA/MAA).
- Strong scientific writing/editing for study reports, IB, CTD Module 2 nonclinical summaries, and related documents.
- Understanding of drug discovery/development, pharmacology, and in vitro/in vivo lab operations.
- Hands-on experience supporting nonclinical drug discovery and early development.
- Strong project management; ability to balance competing priorities and timelines.
- Proficiency with Microsoft Office, data graphing/visualization tools, and document management software.
- Strategic/analytical thinking; clear written/verbal communication; strong attention to detail.
Preferred:
- Experience in therapeutic areas (e.g., oncology, neuroscience, immunology, cardiovascular-metabolic, infectious diseases).
- Knowledge of therapeutic modalities (small molecules, biologics, drug conjugates) and/or vaccines.
- Experience with AI-enabled data retrieval, QC, and scientific writing tools.
- AMWA certificate.