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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. Your work will comply with Precision's Medical Writing Style Guide, SOPs, regulatory guidelines (ICH, FDA, GCP), and eCTD requirements.
Key responsibilities include independently formulating key messages from clinical study data, authoring complex regulatory content, and ensuring smooth document management from template through final approval in collaboration with sponsors, external vendors, and internal teams. You will contribute to the development and maintenance of medical writing processes, SOPs, templates, and work instructions. The role requires strong problem-solving skills, literature-based research capabilities, and the ability to communicate clearly both in writing and verbally with internal and client teams.
You will work in a fast-paced environment managing multiple high-priority projects with minimal instruction on routine work. This is an individual contributor role focused on technical excellence in medical writing rather than people management.
Minimum qualifications: BS degree in a scientific or medical discipline with relevant writing expertise, plus 5+ years as a Senior Medical Writer in sponsor or CRO settings (or 7+ years as a Principal Medical Writer). You must have clear understanding of applicable regulations (ICH, FDA, GCP), clinical trial transparency requirements (EudraCT, CT.gov), and eCTD requirements. Proficiency required in Microsoft Office (Word, Excel, PowerPoint), Teams, Adobe Acrobat, and Windows. Impeccable attention to detail and ability to work independently on complex assignments are essential.
