Principal Regulatory Medical Writer

📋 Description

• Independently develop and manage complex clinical and regulatory documents.
• Author, edit, and review regulatory, clinical, device, and disclosure docs.
• Manage medical writing projects, timelines, and client expectations.
• Coordinate cross-functional collaboration with clinical ops, regulatory, biostatistics, data mgmt.
• Lead quality control and ensure audit trails and compliance.

🎯 Requirements

• Bachelor’s degree in medical/science or related field.
• 7+ years of regulatory medical writing experience in pharma/biotech/medical device.
• Advanced knowledge of clinical research principles.
• Strong understanding of regulatory submission processes and global guidelines.
• Experience with IND, NDA, BLA, MAA, eCTD submissions preferred.
• Excellent proficiency in Microsoft Word with advanced formatting.

🎁 Benefits

• Opportunity to work on global healthcare projects.
• Flexible remote work environment.
• Exposure to innovative clinical research programs.
• Professional development opportunities.
• Collaborative environment with multidisciplinary experts.
• Career growth within a global organization.