Medical writer

• Research, write, and edit clinical documents, including clinical study reports, clinical study protocols, clinical plan outlines, regulatory submission document sections, and scientific manuscripts
• Apply therapeutic expertise, clinical drug development knowledge, and relevant experience to projects involving drugs, biologics, devices, and other products for human use
• Act as Lead Medical Writer on complex projects such as regulatory submissions, CTD modules, and clinical overviews
• Liaise directly with customers on medical writing issues
• Propose costings for less routine projects, out-of-scope activities, and potential budget efficiencies with manager guidance
• Present on project-specific medical writing proposals at full-service bid defence meetings
• Interpret non-clinical and clinical data in technical reports
• Provide senior review and guidance for documents prepared by junior staff
• Design training materials and contribute to generic training plans
• Deliver general Medical Writing training to internal and external groups
• Act as Project Manager for small series of stand-alone Medical Writing projects
• Monitor current data, trends, medical writing and regulatory knowledge, and drug development advances
• Propose SOP revisions and process improvements; draft and review Medical Writing SOPs

Medical writer jobs in Taiwan

Medical Writer – Senior Medical Writer