Clinical Documentation Specialist

🔹 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

specifically summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users

strong ability to identify inconsistencies, gaps, and errors in complex technical content.

accuracy with interpretation and ability to concisely present data

build constructive and effective relationships