Clinical Evaluation Report Writer

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Global Regulatory Writing & Consulting (GLOBAL)

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Global Regulatory Writing & Consulting (GLOBAL) is a professional consulting firm specializing in regulatory writing and consulting services for the medical device, pharmaceutical, and biotechnology industries. GLOBAL provides a wide range of services including regulatory submissions support, strategic writing, and consulting on complex regulatory strategies to help manufacturers bring life-saving products to market efficiently and compliantly. They utilize cutting-edge technology, including AI and machine learning, to deliver high-quality solutions that tackle regulatory hurdles and streamline workflows. GLOBAL serves clients globally from the pre-market phase through to post-market maintenance, ensuring that products meet stringent regulatory requirements and reach patients effectively.

📋 Description

• Independently write, edit, review, and format regulatory submission documents including CERs, CEPs, PMS Plans, PMCF Plans, and SSCPs • Meet project deadlines and conform to client regulatory submission guidelines and internal document standards • Coordinate content development with internal and external multidisciplinary subject matter experts • Attend document-development meetings and provide timelines and document status reports • Mentor and train CER Writers • Collaborate with other writers to improve writing style, terminology harmonization, and team initiatives • Develop CER strategies • Conduct systematic literature reviews, vigilance database searches, and interpretation of results • Synthesize complex technical and clinical information using appropriate formats such as prose, tables, graphics, figures, and flow charts • Manage multiple projects and timelines simultaneously • Interact with clients and vendors as needed

🎯 Requirements

• Minimum of a BA or BS in science, engineering, or medical field; advanced degree strongly preferred • 1–5 years of medical writing experience in the medical device industry or medical writing • Oral and written fluency in English required • Strong command of medical and surgical terminology • Experience writing CEPs and all sections of CERs • Familiarity with SSCPs, PMS Plans, PMS Reports, PSURs, PMCF Plans, and PMCF Reports • Understanding of EU medical-device regulations and guidelines, including MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev. 4, and MDR 2017/745 • Experience working in a regulated industry with high quality, integrity, and scientific-accuracy standards • Proficiency with Microsoft Office 365, including advanced Word and Excel • Experience with Teams, Outlook, SharePoint, and referencing software such as EndNote • Strong understanding of data analysis and statistical methods • Ability to plan and execute systematic literature reviews • Experience with literature management tools such as QUOSA or Distiller is a plus • Vigilance database searching and interpretation, including FDA MAUDE and FDA Recall Database • Ability to synthesize complex technical or clinical information clearly, concisely, and accurately • Strong problem-solving, timeline-management, organizational, and attention-to-detail skills • Ability to manage multiple projects and timelines simultaneously • Ability to develop CER strategies

🏖️ Benefits

• Fully remote position • Occasional travel for team retreats, client-facing meetings, and conferences (<10%)