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.