Criterion Edge

Content Writer

• Produce regulatory and scientific reports, plans, and other written deliverables for medical device, pharma/biotech, and in vitro device clients
• Write documents or document sections on assigned projects
• Organize project workload and tasks, identify project needs, and adhere to timelines
• Understand and meet client expectations through teamwork, deadlines, problem-solving, and scientific knowledge
• Collaborate with the project writing team
• Document assigned tasks, time estimates, and due dates in Asana project plans with the Project Manager
• Provide weekly progress updates
• Ensure document data are clear, complete, accurate, and concise
• Ensure statements and conclusions are integrated, balanced, data-supported, and consistent across related documents
• Address expert and scientific review comments and revise content based on internal and external feedback
• Stay current with medical writing best practices and relevant regulatory knowledge
• Identify project risks and bring them to the project team for resolution
• Participate in quality control checks following internal QC processes
• Provide written and verbal feedback to junior staff and managers
• Mentor junior staff when requested
• Maintain effective professional relationships with co-workers, managers, and clients
• Exercise initiative and sound judgment when handling unfamiliar project requirements or document challenges
• Seek clarification from the Project Lead or Project Management before proceeding

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Medical Device Writer