Medical Writer

🔹 Designation: Deputy Manager – Medical Writing 🔹 Role Type: Individual Contributor 🔹 Experience Required: 3+ Years 🔹 Work Location: Remote (India) 🔹 Travel Requirement: May require monthly/quarterly travel to Gurgaon office based on business needs Essential / Key Job Responsibilities (including supervisory and/or fiscal): - Experience writing CEPs, CERs, and PMCF Plans and Reports. - Understanding of current regulatory and clinical requirements (e.g., European clinical requirements, including MDR, MEDDEV 2.7.1) - Perform clinical evaluation, including planning, identification, appraisal, analysis, and reporting of clinical data. Prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files/dossiers/registrations as required and per applicable SOPs. Ensure compliance with the applicable regulations and guidance documents. - Author and maintain PMCF Plans and PMCF Reports in accordance with EU Medical Device Regulation and applicable regulations and guidance documents. Collaborate with cross-functional teams to define PMCF objectives, methodologies, and data sources. Interpret PMCF findings and integrate them into CERs, Risk Management documentation, and other regulatory deliverables. - Coordinate with various departments (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to assess and identify the necessary preclinical, clinical, and technical information. - Generate and track timelines. Follow through on all tasks and ensure quality results. - Develop or revise templates, SOPs, or guidelines for regulatory, medical, and clinical documents. - Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies. - Participate in post-market surveillance activities by leading routine systematic literature reviews (e.g., screen articles against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for specific medical device groups or sub-groups. - Organize and incorporate information, such as references, graphics, tables, and data listings, for the creation of robust and compliant technical documents. - Critically write and edit scientifically complex documents with substantial intellectual content. - Ensure content is clear, complete, accurate, and aligned with source documents. Conduct peer review (quality control) for documents authored by other medical writers. - Maintain knowledge of current internal and external standards, regulations, and technologies related to this function. - Excellent writing skills and the ability to communicate correctly and persuasively in English and to use medical terminology accurately - In-depth working knowledge of Microsoft Office products - Ability to manage multiple projects, interact with multi-disciplinary teams, and work independently with minimal supervision - Ability to quickly acquire and apply understanding of therapeutic areas, medical device portfolios, business objectives, technical skills, and clinical data/evidence - Ability to use judgment based upon standards, policies, and meeting timelines - Good problem-solving and analytical skills; anticipate problems, issues, and delays; proactively look to minimize the impact on the project - Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users - Excellent attention to detail; strong ability to identify inconsistencies, gaps, and errors in complex technical content. - Knowledge of narrative and systematic literature reviews; accuracy with interpretation and ability to concisely present data - Excellent understanding of scientific or clinical research and methods - Establish rapport and collaborate with other (internal and external) team members; build constructive and effective relationships