Senior Medical Writer/Principal Medical Writer

📋 Description

• Lead planning, writing, editing, formatting, and QC review of clinical documents (protocols
• Manage document development workflows from templates to final approval with sponsors, vendors, and
• Interpret study data to develop clear key messages and scientific content.
• Apply medical writing expertise to regulatory documents ensuring compliance and accuracy.
• Conduct literature research to support writing activities.
• Ensure deliverables comply with ICH, FDA, GCP, and eCTD standards.

🎯 Requirements

• Bachelor’s degree or equivalent in a scientific/medical discipline with medical writing experience.
• 5+ years as a Senior Medical Writer in sponsor/CRO environment, or 7+ years as Principal Medical
• Strong understanding of clinical development, regulatory requirements, and trial documentation
• Experience with ICH, FDA, GCP, clinical trial transparency, and eCTD submission standards.
• Proven ability to author complex clinical documents and translate data into content.
• Excellent written and verbal communication; ability to collaborate with clients and

🎁 Benefits

• Competitive salary: $101,800 - $184,700 USD depending on experience and location.
• Eligibility for discretionary annual bonus.
• Health insurance, retirement benefits, life and disability benefits, parental leave.
• Paid time off including vacation and sick leave.
• Opportunity to work on impactful clinical programs in a collaborative environment.
• Professional growth within a global healthcare and life sciences organization.