Principal Medical Writer
Core
Lead authoring and strategic planning for clinical and regulatory documents including protocols, clinical study reports, briefing documents, and submission dossiers for HIV medicines.
Role type
Principal Medical Writer (Regulatory & Clinical)
Builds
Regulatory submission dossiers and clinical study reports for HIV prevention and treatment medicines.
Domain
Pharmaceutical / HIV therapeutics
Required skills
Medical writing, Regulatory submissions, Clinical protocols, Clinical study reports, Common Technical Document (CTD), ICH guidelines, Good Clinical Practice (GCP), Scientific writing, Strategic planning, Project management
Preferred skills
Advanced degree (PhD, PharmD, MPH, MS), Leading regulatory submission projects, Statistical data interpretation, Multicultural team collaboration, Process improvement
Technologies
None explicitly stated
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 audit readiness.
Seniority
Principal, hands-on IC with leadership responsibilities
