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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. The role requires independent formulation of key messages from clinical study data and authoring complex regulatory content with deep understanding of ICH, FDA, GCP, and eCTD requirements.
Key responsibilities include:
- Planning and executing clinical document development from template through final approval
- Ensuring smooth document management and collaboration with sponsors, vendors, and internal teams
- Performing literature-based research to support writing activities
- Contributing to development and maintenance of medical writing processes, SOPs, and templates
- Communicating clearly with internal and client teams on complex regulatory matters
- Problem-solving in a fast-paced, multi-project environment
You will work independently on routine assignments with minimal instruction on new work, managing multiple high-priority projects simultaneously. The role demands impeccable attention to detail, strong regulatory knowledge, and the ability to translate clinical data into clear, compliant documentation.
Required qualifications: BS in a scientific or medical discipline with 5+ years as a Senior Medical Writer in sponsor/CRO settings (or 7+ years as Principal Medical Writer). Proficiency with Microsoft Office suite, Adobe Acrobat, and Teams. Clear understanding of applicable regulations, clinical trial transparency requirements, and eCTD standards across all development phases.
