Deputy Manager, Medical Writing

Job Description Job Description Summary The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation, post-market clinical follow-up (PMCF) documentation and other related documentation, primarily Clinical Evaluation Plans and Reports (CEPs and CERs) and PMCF Plans and Reports. The role may focus on authoring, quality control (QC), or a combination, depending on the candidate's strengths and team needs. Responsibilities include developing high-quality documents to ensure clarity, accuracy, and compliance with applicable standards, in alignment with project timelines and priorities. This role provides flexibility to work remotely. Job Description P3-12892 Essential / Key Job Responsibilities (including supervisory and/or fiscal): . 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. Required Qualifications: . 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 Preferred Qualifications: . 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) Education and/or Experience: . Bachelor's degree (or advanced degree) preferred with a focus in the sciences, a medical-related field, or medical/technical writing plus 1-3 years of medical device experience OR 5+ years of medical device experience Required Skills Optional Skills . Primary Work Location IND Gurgaon - Aurbis Summit Additional Locations Work Shift