Principal Medical Writer
Core
Lead complex scientific publications and clinical regulatory document preparations (filings, dossiers, manuscripts) for multiple compounds within a therapeutic area.
Role type
Principal Medical Writer (Scientific Content Expert)
Builds
Clinical regulatory submissions, scientific manuscripts, abstracts, posters, and comprehensive data packages.
Domain
Life Sciences / Healthcare / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing expertise, clinical regulatory document preparation, therapeutic area knowledge, US and international regulations compliance, data interpretation, process improvement, cross-functional team leadership, statistical concepts understanding, electronic document management systems proficiency.
Preferred skills
Advanced degree (Master's/PhD), AMWA certification, pharmaceutical editing/writing specialty, project management experience.
Technologies
eCTD, COSMOS, journal/congress databases, word processing tools, flow diagram software, spreadsheets.
Responsibilities
Serve as medical writing lead for complex filings and dossiers; act as subject matter expert for assigned therapeutic areas; convert data into compliant regulatory formats; maintain expert knowledge of clinical regulations; mentor junior writers; coordinate review meetings and resolve document content issues; ensure compliance with journal/congress guidelines and SOPs.
Seniority
Senior, hands-on IC with mentorship responsibilities