Job Description
📋 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.
