Senior Medical Writer/Principal Medical Writer

📋 Description

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

🎯 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, or 7+ years as Principal Medical Writer.
• Strong understanding of clinical development processes and regulatory requirements.
• Experience with ICH, FDA, GCP, transparency, and eCTD submission standards.
• Proven ability to author complex clinical documents and synthesize data into content.
• Excellent written/verbal communication and collaboration with clients and cross-functional teams.

🎁 Benefits

• Competitive salary (USD) depending on experience and location.
• Discretionary annual bonus program.
• Comprehensive health insurance, retirement benefits, life and disability insurance.
• Parental leave, paid time off, vacation and sick leave.
• Opportunity to work on impactful clinical research in a collaborative environment.
• Professional growth opportunities within a global healthcare organization.