Senior Medical Writer/Principal Medical Writer

📋 Description

• Plan, write, edit, format, and perform QC review of clinical study documents including protocols
• Ensure smooth and effective document management from template to final approved version in
• Independently formulate key messages from clinical study data
• 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

🎯 Requirements

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
• 5+ years of experience as a Sr. Medical Writer in sponsor and/or CRO setting, or 7+ years as a
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
• Clear understanding of applicable regulations (ICH, FDA, GCP), clinical trial transparency
• 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