Description Job title: Lead Medical Writer Department: R&D Clinicals Location: Chandlers Ford, Eastleigh GLS: P04 Working hours: Monday – Friday 37.5 hours per week. Onsite role 5 days a week A brighter future awaits you CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses. Job summary – What to expect: The medical writing team is responsible for creating and ensuring the scientific validity of clinical-related documentation generated for regulatory purposes, specifically EU-MDD and MDR compliant CEPs/ CERs. Liaising with internal functions on cross-functional teams, such as Clinical, Post Market Surveillance, Regulatory, Commercial, Manufacturing, Quality and R&D. As the Lead Medical Writer in our R&D clinical team, you will provide insights and expertise on regulatory gap closures and best practices as well as conduct clinical-related technical writing for medical device regulatory projects (CER, MDD/ MDR compliant format, literature review and analysis). You will also support clinical projects including study reports and manuscripts. Specifically you will: Be a subject matter expert in implementing CER strategies and interfaces with project team members, both within the organization and with a diverse range of external groups, to drive deliverables to completion Serve as the lead for implementing or improving Clinical Evaluation procedures and systems. Develop approaches and methodologies based on established, changed and new legislation, regulation and guidance documentation. Specifically, with the existing MDD and new EU MDR requirements, including those outlined in existing and emerging EU Commission’s CER MDCG guidance Collect, summarise, and analyse CERs for periodic review as per regulatory guidance such as MDCG 2020-5, 2020-6, Regulation (EU) 2017/745 on Medical Devices (MDR), Council of the European Union, MEDDEV 2.7/1. Stay abreast of all pertinent regulatory affairs issues, including MDCG guidance. Interprets and applies FDA regulations to business practices and provides regulatory input, advice and guidance to the organization Follow-up on the progression of technical documentation activities required to successfully and timely complete the deliverables Periodically review medical literature for new information that may warrant supplemental updates to CERs as applicable (e.g., if new risks are identified) and for reporting of device safety and performance data Conduct comprehensive literature searches for product/technology evaluations to support product development, risk analysis, regulatory submissions, due diligence efforts. Write and/or editorial review (for accuracy/clarity) of core clinical study documentation for submission to regulatory agencies, for distribution to investigational centers, or intra-company use, including: study protocols, investigator brochures, risk/benefit and integrated summaries from raw data (i.e., aggregate adverse event narratives), compiling, analyzing and summarizing data for comprehensive study reports, tables, charts, figures, and other visual display elements for presenting clinical data Assist members of the Clinical Affairs team in effective visual and written communication, including manuscripts and conference presentations As needed, project management of Clinical Research Organizations (CRO) conducting post-market follow-up (PMCF) clinical studies when CooperVision is considered the Sponsor A full job description is available upon request. About you: We are looking for someone who comes with the following experience: Significant experience in Medical Device/Scientific Technical Writing as a subject matter expert in a similar Lead Medical Writing position. Direct experience in creating clinical-related documents for Clinical Evaluation submission clinical evaluation reports, plans, interactions with notified bodies, drafting docs. Extensive knowledge of the EU Medical Device Directive and Medical Device Regulation to help inform procedures. Drafting EU MDR Clinical Evaluation Plans /Clinical Evaluation Reports. Literature analysis, including managing a writing project from start to end. Cross functional understanding of Design Control and Clinical Affairs. What we offer: You’ll receive competitive compensation and a fantastic benefits package including; 25 days holiday, 10% Bonus, pension scheme, private medical, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more! We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours. We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision. Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities. Qualifications LI-GA1 LI-ONSITE INDHP