Senior Medical Writer/Principal Medical Writer

Position Summary

The Senior Medical Writer/Principal Medical Writer will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.

Essential Functions

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

Qualifications

Minimum Required:

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
• 5+ years of experience as a medical writer in the sponsor and/or CRO setting

Other Required:

• Proficiency with Microsoft Windows, Te