Description

The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) to support BD product registration efforts in the EU market. The candidate will lead CEP and CER writing activities and work closely with other departments and functions to ensure the development of high-quality documents in alignment with project timelines and priorities. This role provides flexibility to work remotely. Essential / Key Job Responsibilities: 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. Coordinate with various departments (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to assess and identify the necessary preclinical, clinical, and technical information. Perform gap analyses and revise existing CERs for legacy products against the EU Medical Device Regulation. 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. 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 Knowledge of narrative and systematic literature reviews; accuracy with interpretation and ability to concisely present data is a must 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 CERs 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

Role and Responsibilities

• The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) to support BD product registration efforts in the EU market. The candidate will lead CEP and CER writing activities and work closely with other departments and functions to ensure the development of high-quality documents in alignment with project timelines and priorities. This role provides flexibility to work remotely. Essential / Key Job Responsibilities: 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. Coordinate with various departments (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to assess and identify the necessary preclinical, clinical, and technical information. Perform gap analyses and revise existing CERs for legacy products against the EU Medical Device Regulation. 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. 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 Knowledge of narrative and systematic literature reviews; accuracy with interpretation and ability to concisely present data is a must 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 CERs 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