Senior Specialist, Nonclinical Medical Writing
Core
Generate preclinical reports and regulatory submission modules to support drug development programs from FIH to global marketing applications.
Role type
Senior Specialist, Nonclinical Medical Writer
Builds
Preclinical reports, integrated pharmacology summaries, and regulatory documents for internal filing and submission.
Domain
Pharmaceutical/Biotech, Nonclinical Pharmacology, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, Regulatory compliance, Pharmacology principles, Drug discovery process knowledge, Project management, Data analysis and synthesis, Scientific editing, Document management
Preferred skills
Oncology/Neuroscience/Immunology therapeutic area knowledge, Biologics/Vaccine development experience, AI-enabled writing tools proficiency, AMWA certification
Technologies
Microsoft Office, Data graphing and visualization tools, Document management software
Responsibilities
Coordinate generation of preclinical reports and regulatory submission modules; Conduct data collection and QC for nonclinical datasets; Author and edit pharmacology study reports and regulatory documents; Develop writing templates and guidelines; Evaluate and adopt new digital/AI tools for writing efficiency.
Seniority
Senior, hands-on IC
