Medical Device Writer
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Job Description
Remote Medical Writer producing regulatory and scientific deliverables for medical device, pharma/biotech, and in vitro device clients. Writing CERs and supporting literature reviews, QC, and project teams.
Responsibilities:
- 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
Requirements:
- 2+ years of direct writing experience in pharmaceutical, medical device, in vitro device, or related academic fields
- Minimum of a BSc in a life sciences or related discipline / related field
- Advanced word processing skills, including Microsoft Office (including Word), Adobe Acrobat, Excel, and collaborative document sharing platforms such as SharePoint
- Ability to learn and adapt to various IT systems
- Familiarity with all current and applicable guidelines and regulations governing the assigned project
- Knowledge of and experience with systematic literature review (SLR) methodology and best practices, including Level 1 and Level 2 literature screening, data extraction, and weighting and appraisal of data sets
- High level of English fluency or native English speaker
- Excellent oral, presentation, written, grammatical, and technical writing skills
- Ability to interact confidently with external stakeholders and communicate effectively and clearly
- Ability to work independently with minimal supervision
- Ability to produce high-quality written deliverables according to customer and project requirements and agreed timelines
- Excellent attention to detail and accuracy
- Demonstrated scientific rigor and understanding of the scientific process in written documents
Benefits:
- Remote work arrangement
- Opportunity to work with a best-in-class writing team
- Collaboration with writers, project managers, and support specialists
- Training and development opportunities through project mentorship
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