Senior Specialist, Nonclinical Medical Writing
Merck · South San Francisco (grand Ave), CA
Medical AffairsFull-time$131k–$207kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Merck seeks an experienced medical writer to develop preclinical reports and regulatory submission modules supporting drug development from first-in-human through marketing approval. The role involves managing multiple programs, synthesizing nonclinical data, and ensuring compliance with regulatory standards across diverse therapeutic areas.
What they're looking for
- Bachelor's degree with 7+ years, Master's with 4+ years, or Ph.D. with 1+ year in biology, pharmacology, or related discipline
- Expertise in regulatory filings (CTD, IND, CTA, IMPD, NDA/BLA/MAA) and nonclinical submission modules
- Strong scientific writing and editing skills for study reports, investigator's brochures, and regulatory documents
- Solid understanding of drug discovery, development processes, and pharmacology principles
- Hands-on experience supporting nonclinical drug discovery and early development programs
- Strong project management and stakeholder coordination abilities with competing priorities
- Proficiency with Microsoft Office, data visualization tools, and document management systems
What you'll be doing
- Coordinate generation of preclinical reports and regulatory submission modules, managing scope, timeline, and approval processes
- Collect and quality-control preclinical data to ensure integrity and regulatory compliance
- Analyze and synthesize nonclinical datasets to develop integrated scientific narratives across pharmacology and efficacy findings
- Author, edit, and submit pharmacology study reports and integrated summaries to internal filing systems
- Evaluate and adopt new digital and AI tools to improve scientific writing efficiency and document quality
Privacy & handoff
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