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Precision for Medicine seeks a Senior Medical Writer to lead the development of high-quality, timely clinical study documents. You will be responsible for planning, writing, editing, formatting, and QC review of clinical documents including protocols, investigator's brochures, informed consent forms, DSURs, and clinical study reports. You will ensure compliance with Precision's Medical Writing Style Guide, SOPs, regulatory guidelines (ICH, FDA, GCP), and eCTD requirements.
Key responsibilities include:
- Planning, writing, editing, formatting, and QC review of complex clinical documents with clear understanding of regulatory content requirements across all development phases
- Managing document workflows from template through final approval in collaboration with sponsors, external vendors, and internal teams
- Independently formulating key messages from clinical study data
- Authoring complex content using deep knowledge of medical writing processes and regulatory requirements
- Clear written and verbal communication with internal and client teams
- Contributing to development and maintenance of medical writing processes, SOPs, templates, and work instructions
- Literature-based research to support writing activities
- Problem-solving in fast-paced, multi-project environments
You will need a BS in a scientific or medical discipline with 5+ years of experience as a Senior Medical Writer in sponsor or CRO settings (or 7+ years as a Principal Medical Writer). Required skills include proficiency with Microsoft Office suite, Adobe Acrobat, and Teams; clear understanding of ICH, FDA, and GCP regulations; knowledge of clinical trial transparency requirements (EudraCT, CT.gov); and eCTD requirements. You must demonstrate impeccable attention to detail, ability to manage multiple high-priority projects independently, and thrive in fast-paced environments.
