Senior Medical Writer​/Principal Medical Writer

Position Summary

The Senior Medical Writer/Principal Medical Writer will lead the development of high‑quality, on‑time clinical study documents. Responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Documents are developed in compliance with the Precision Medical Writing Style Guide, Precision SOPs, applicable regulatory guidelines (ICH, FDA, GCP), and eCTD requirements.

• Planning, writing, editing, formatting, and QC review of timely and high‑quality clinical documents including protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives, with a clear understanding of content requirements based on regulatory guidance.
• Ensures smooth and effective document management from start to finish (from template to final approved version) in collaboration with sponsor, external vendors, or internal Precision project teams/departments.
• Formulate key messages from clinical study data independently.
• Author complex content using knowledge/skills and understanding of processes.
• Communicate clearly and concisely in writing and verbally with internal and client teams.
• Contribute to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents.
• Excellent problem‑solving skills.
• Perform literature‑based research to support writing activities.
• Other duties as assigned.

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
• 5+ years of experience as a Senior Medical Writer in a sponsor and/or CRO setting, or 7+ years as a Principal Medical Writer.

• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Clear understanding of applicable regulations (ICH, FDA, GCP), clinical trial transparency requirements (EudraCT, CT.gov), and 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, with little instruction on routine work and minimal instruction on new assignments.

• Advanced degree (MS/PhD).
• Oncology and/or rare disease experience, especially protocol and CSR development.

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