Scientist III, Medical Writing
Core
Transform complex scientific and clinical data into clear, accurate, and high-quality regulatory and non-regulatory documentation for pharmaceutical, biotechnology, and medical device clients.
Role type
Senior IC medical writer (regulatory sciences)
Builds
Regulatory submissions (eCTD), clinical study reports, protocols, and briefing books for global health clients
Domain
Life sciences / Regulatory affairs / Medical writing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, regulatory document authoring, clinical data translation, ICH/FDA/EMA guideline knowledge, statistical analysis plan review, version control management
Preferred skills
Experience with Veeva, strategic contribution to submission teams, data analysis planning
Technologies
Veeva, MS Office
Responsibilities
Write and edit clinical regulatory documents (CTD Module 2 summaries, CSRs, protocols, Investigator Brochures); contribute scientific expertise to submission teams; review statistical analysis plans; ensure documents meet regulatory requirements and timelines; manage version control across stakeholders
Seniority
Mid-level, hands-on IC
