Senior Medical Writer/Principal Medical Writer

📋 Description

• Plan, write, edit, format, and QC clinical documents (protocols, IBs, ICF templates)
• Manage document lifecycle from template to final approved version with sponsor/vendors
• Independently formulate key messages from clinical study data
• Author complex content with regulatory knowledge and processes
• Communicate clearly with internal and client teams
• Contribute to development and maintenance of MW processes, SOPs, templates

🎯 Requirements

• BS degree or equivalent in a scientific/medical field with writing expertise
• 5+ years as Sr Medical Writer or 7+ years as Principal Medical Writer
• Proficiency with MS Windows, Teams, Word, Excel, Adobe Acrobat, PowerPoint
• Strong understanding of ICH, FDA, GCP, EudraCT, CT.gov, and eCTD requirements
• Excellent attention to detail and ability to manage multiple high-priority projects
• Advanced degree (MS/PhD) preferred

🎁 Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation