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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