Deputy Manager, Medical Writing

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 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