Senior Medical Writer/Principal Medical Writer

Overview

In this role you will lead the development of high-quality clinical study documents, ensuring timely delivery and adherence to regulatory standards. You will work with sponsor teams, vendors, and internal Precision project groups to plan, write, edit, format, and QC documents across development stages. You will translate study data into clear, compliant messages while maintaining meticulous attention to detail. This position offers the opportunity to shape medical writing processes and contribute to regulatory-ready documentation in a fast-paced environment. You will operate at the intersection of science and regulation, delivering impactful documents that support clinical development and eC

Responsibilities

• Plan, write, edit, format, and QC clinical documents (protocols, IBs, ICF templates, DSURs, CSRs,CSR narratives)
• Ensure documents comply with style guides, SOPs, regulatory guidelines (ICH, FDA, GCP) and eCTD requirements
• Manage document workflow from template to final approved version with sponsors, vendors, and internal teams
• Independently extract key messages from clinical data and craft complex content
• Contribute to medical writing processes, templates, SOPs, and work instructions
• Perform literature-based research to support writing
• Communicate clearly with internal and client teams

Key requirements

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
• 5+ years as a Senior Medical Writer in sponsor/CRO setting or 7+ years as Principal Medical Writer
• Proficiency with Windows, Teams, Word, Excel, Adobe Acrobat, PowerPoint
• Strong understanding of ICH, FDA, GCP, clinical trial transparency (EudraCT, CT.gov) and eCTD
• Impeccable attention to detail and timely completion of writing assignments
• Ability to work in a fast-paced environment with multiple high-priority projects

• excellent written and verbal communication
• problem-solving
• self-motivated with minimal instruction
• clinical document writing
• QC and editing
• literature research

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