Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated
Core
Lead the development of high-quality regulatory and clinical documents across Phase 2 and Phase 3 studies, including protocols, CSRs, and submission materials.
Role type
Senior IC regulatory medical writer (sponsor-dedicated)
Builds
Regulatory submissions (NDA, eCTD), Clinical Study Reports, Investigator Brochures, Integrated Summaries of Efficacy and Safety
Domain
Life Sciences / Clinical Development / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Lead regulatory medical writing, Phase 2/3 clinical development, CTD Modules 2.7.3/2.7.4, ISE/ISS preparation, Clinical Study Reports, Investigator Brochures, Protocol writing, Regulatory guidelines (ICH E3), Project management, Client collaboration, Scientific writing and editing
Preferred skills
Safety aggregate reports, Briefing books, Clinical literature search, Process improvement, Mentoring
Technologies
eCTD, ICH E3
Responsibilities
Lead preparation and delivery of regulatory-compliant medical writing deliverables; Develop and oversee protocols, CSRs, IBs, and submission materials; Coordinate medical writing activities and manage document reviews; Apply regulatory standards and guidelines; Provide technical guidance and mentor less experienced writers; Monitor project budgets and timelines
Seniority
Senior, hands-on IC with leadership responsibilities
