Deputy Manager, Medical Writing

Job Description SummaryThe 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

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Primary Work LocationIND Gurgaon - Aurbis SummitAdditional LocationsWork Shift

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