Medical Device Writer

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🔥 8 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✏️ Content Writer

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

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Criterion Edge

WebsiteLinkedInAll Job Openings

11 - 50 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success for Medical Device, Pharma, and In Vitro Diagnostics companies through expert regulatory, scientific, and clinical writing services. With a team of seasoned regulatory writers and medical librarians, Criterion Edge collaborates with its clients to produce high-quality, compliant documentation that meets global regulatory standards and accelerates approval timelines.

📋 Description

• 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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