Senior Medical Writer/Principal Medical Writer

. Lead development of high-quality, on-time clinical study documents .

Posted 9/30/2026full-timeRemote • RomaniaSenior💰 $100,600 - $182,600 per yearWebsite

Tools & technologies

Google Cloud Platform

Key responsibilities & impact

Lead development of high-quality, on-time clinical study documents
Plan, write, edit, format, and perform QC review of clinical documents, including clinical study protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives
Develop documents in compliance with Precision MW Style Guide, Precision SOPs, ICH, FDA, GCP, and eCTD requirements
Manage documents from template through final approved version in collaboration with sponsors, external vendors, and internal Precision project teams/departments
Independently formulate key messages from clinical study data
Author complex content using knowledge of relevant processes
Communicate clearly and concisely with internal and client teams
Contribute to medical writing processes, SOPs, templates, and work instructions
Perform literature-based research to support writing activities
Perform other duties as assigned

What you’ll need

BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
5+ years of experience as a Sr. Medical Writer in the sponsor and/or CRO setting, or 7+ years of experience as a Principal Medical Writer
Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
Clear understanding of applicable regulations, including ICH, FDA, and GCP
Understanding of clinical trial transparency requirements, including EudraCT and CT.gov
Understanding of eCTD requirements for all phases of development
Impeccable attention to detail and ability to complete writing assignments in a timely manner
Ability to work effectively in a fast-paced environment with multiple high-priority projects
Advanced degree (MS/PhD) preferred
Oncology and/or rare disease experience preferred