Principal Medical Writer
Core
Lead authoring and strategic planning for complex clinical and regulatory documents including protocols, clinical study reports, and submission dossiers for HIV medicines.
Role type
Principal Medical Writer (Regulatory & Clinical Development)
Builds
Regulatory submission dossiers (CTD) and clinical study reports for HIV prevention and treatment medicines
Domain
Pharmaceutical industry, HIV therapeutics, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, Regulatory writing, Clinical protocol authoring, Clinical study report authoring, CTD module development, ICH guidelines knowledge, GCP knowledge, Scientific narrative translation, Project management, Audit readiness
Preferred skills
Advanced degree (PhD/PharmD/MPH), Leading regulatory submission projects, Statistical data interpretation, Multicultural team collaboration, Strategic thinking
Technologies
Common Technical Document (CTD), ICH guidelines, GCP
Responsibilities
Lead authoring and strategic planning for clinical and regulatory documents; Manage end-to-end writing projects coordinating contributors and timelines; Translate complex clinical data into clear scientific narratives; Act as subject matter expert on medical writing standards; Drive process improvement initiatives and support audit readiness
Seniority
Senior, hands-on IC with strategic oversight
