Principal Medical Writer - FSP
Core
Lead Medical Writer responsible for preparing clinical study reports, protocols, and other regulatory documents for the life sciences industry.
Role type
Senior IC medical writer (clinical research)
Builds
Clinical study reports, protocols, and regulatory documents for pharmaceutical and biotech clients
Domain
Life sciences / Clinical research / Medical writing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study report (CSR) authoring, protocol writing, regulatory compliance (GCP), statistical analysis interpretation, budget forecasting, project management, mentorship
Preferred skills
Ph.D. in life sciences, experience acting as project manager, customer lead roles
Technologies
None explicitly stated
Responsibilities
Lead and prepare assigned medical writing documents including CSRs and protocols; negotiate timelines and resolve customer comments; review and approve project budgets and costings; mentor junior staff and deliver training; represent the team in bid defense meetings and cross-functional initiatives
Seniority
Senior, hands-on IC with leadership responsibilities
