Principal Medical Writer
Core
Lead complex scientific publications and clinical regulatory document preparations for clinical teams, ensuring submission-ready quality and process implementation.
Role type
Principal Medical Writer (Clinical Regulatory & Scientific Publishing)
Builds
Scientific publications, clinical regulatory dossiers, and comprehensive data packages for new and updated submissions.
Domain
Healthcare / Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical regulatory document preparation, scientific content interpretation, US and international regulatory compliance, therapeutic area expertise, electronic document management systems, Common Technical Document templates, statistical concepts, project management, cross-functional team coordination
Preferred skills
Advanced degree, AMWA certification, editing/writing specialty, pharmaceutical specialty
Technologies
COSMOS, eCTD, journal/congress databases, word processing, flow diagrams, spreadsheets, Windows environment
Responsibilities
Lead complex scientific publications and clinical regulatory filings; serve as subject matter expert for assigned therapeutic areas; convert data into compliant regulatory formats; maintain expert knowledge of US and international regulations; coordinate review meetings and resolve document content issues; implement tactical process improvements.
Seniority
Senior, hands-on IC with mentorship responsibilities