Medical Writer
- Prepare and update EU Clinical Evaluation Reports (CERs) and summarize relevant literature to support technical files, dossiers, registrations, and other regulatory documentation in accordance with applicable SOPs, regulations, and guidance documents.
- Coordinate with a variety of cross-functional partners (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to access and identify necessary preclinical, clinical, and technical information.
- Generate and track timelines, follow through on tasks and ensure high-quality results.
- Develop or revise templates, SOPs, or guidelines for regulatory, medical, or clinical documentation.
- Conduct scientific literature reviews and compile reports, including literature updates and periodic safety updates.
- Lead routine systematic literature reviews for specific medical device groups or sub-groups, including screening articles against eligibility criteria, extracting data from included studies, interpreting results, and synthesizing the data into formal reports.
- Organize and incorporate references, graphics, tables, and data for the creation of large, technical documents.
- Write and edit scientifically complex documents for substantial intellectual content.
- Maintain knowledge of internal and external standards, regulations, and technologies.
- Bachelor’s degree in the sciences, medical-related field, or medical/technical writing and 1-3 years of medical device experience OR at least 5 years of medical device experience.
- Experience or understanding of scientific or clinical research and methods.
- Working knowledge of Microsoft Office Products.
- Ability to interpret statistical results of clinical studies and summarize findings clearly and accurately.
- Ability to collaborate effectively with Medical Writing team members and cross-functional stakeholders.
- Advanced degree in the sciences, medical-related field, or medical/technical writing.
- Experience writing CEPs, CERs, and PMCF Plans and Reports.
- Understanding of current regulatory and clinical requirements (e.g., EU-MDR)
- Knowledge in narrative and systematic literature reviews; accuracy with interpretation and presentation of data.
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