Senior Medical Writer

Position Overview

The Senior Medical Writer (MW) will lead the development of high‑quality, on‑time clinical study documents, ensuring compliance with Precision MW Style Guide, SOPs, regulatory guidelines (ICH, FDA, GCP) and eCTD requirements.

• 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

• 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

• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and Power Point
• Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, Eudra
  
  CT, 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 minimal instruction on routine work and new assignments

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

Salary Range: $101,800 - $152,600

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.