
Healthcare Insurance • Biotechnology • Medical Devices
Philips is a global health technology company committed to improving people's health and well-being through meaningful innovation. They focus on various domains including personal health, diagnosis and treatment, and connected care, striving to provide advanced technologies and solutions that enhance health outcomes for individuals and healthcare providers alike.
Yesterday
🇺🇸 United States – Remote
đź’µ $71.3k - $134.4k / year
⏰ Full Time
🟢 Junior
🦅 H1B Visa Sponsor

Healthcare Insurance • Biotechnology • Medical Devices
Philips is a global health technology company committed to improving people's health and well-being through meaningful innovation. They focus on various domains including personal health, diagnosis and treatment, and connected care, striving to provide advanced technologies and solutions that enhance health outcomes for individuals and healthcare providers alike.
• authoring and maintaining clinical and post-market documentation such as CEPs, CERs, PMCFPs, and PMCFRs • contributing to authoring other technical documents that support Clinical, Regulatory, Risk Management, or Post-Market Surveillance efforts • enforcing rigorous adherence to Good Documentation Practices, maintaining quality and accuracy of document content and format • handling development of clinical evaluation deliverables for new products • updating existing company CEPs, CERs, and PMCFP/Rs in strict accordance with MEDDEV 2.7.1, Rev. 4 guidelines and compliant with EU MDR regulations • compiling and synthesizing a wide array of data types and sources to conduct comprehensive evaluations of medical device safety and performance • collaborating with the team to generate accurate and compliant documents by applying standard software tools and procedures • analyzing complex issues and identifying opportunities to improve or adapt existing methods and processes
• some experience in scientific writing (publications, white papers, brochure writing, etc.) required • medical writing experience in the medical device industry strongly preferred • strong comfortability and experience working within GDP and knowledge of relevant writing styles (e.g., AMA) • strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics is preferred • ability to identify, mitigate and escalate risks, prioritize and meet multiple project deadlines • excellent written English and oral communications skills with strong attention to detail related to consistency, grammar, syntax, and accuracy • advanced microsoft office formatting and data analysis skillsets required (pivot tables, table formatting in word, etc.) • PhD/MD/PharmD in a scientific or medical discipline required
• generous PTO • 401k (up to 7% match) • HSA (with company contribution) • stock purchase plan • education reimbursement
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