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.