Senior Medical Writer/Principal Medical Writer
Core
Leading the development of high-quality, on-time clinical study documents including protocols, IBs, CSRs, and patient narratives in compliance with regulatory guidelines.
Role type
Senior/Principal Medical Writer (Clinical)
Builds
Clinical study documents (protocols, IBs, ICFs, DSURs, CSRs) for regulatory submission
Domain
Clinical research / Regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical document planning, writing, editing, formatting, QC review, regulatory compliance (ICH, FDA, GCP), eCTD requirements, clinical study data analysis, SOP development, literature-based research
Preferred skills
Oncology experience, rare disease experience, protocol development, CSR development
Technologies
Microsoft Word, Excel, PowerPoint, Adobe Acrobat, Teams
Responsibilities
Plan, write, edit, format, and QC review clinical study documents; ensure effective document management from template to final approved version; formulate key messages from clinical study data; author complex content; contribute to development of medical writing processes and templates; perform literature-based research
Seniority
Senior, hands-on IC
