Description Job title: Lead Medical Writer Department: Research & Development Location: Southampton, UK (open to discuss relocation packages) GLS: P04 Working hours: 37.5 hours per week Mon-Fri A brighter future awaits you What to expect: As Lead Medical Writer, you’ll 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’ll also support clinical projects including study reports and manuscripts. Essential Functions & Accountabilities: Serves as 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 Serves 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 Collects, summarizes, and analyses 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. Data may include scientific literature review, post-market surveillance, biological evaluation, technical documentation, and clinical investigations. Ability to identify clinical risks that may require support for product safety, liaison with Clinical and Regulatory groups, as applicable Stays 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 Active follow-up on the progression of technical documentation activities required to successfully and timely complete the deliverables Periodically reviews 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 Conducts comprehensive literature searches for product/technology evaluations to support product development, risk analysis, regulatory submissions, due diligence efforts. Writing ad hoc reports based on these literature searches for internal distribution or regulatory submission Writes and/or editorial review (for accuracy/clarity) of core clinical study documentation for submission to regulatory agencies, for distribution to investigational centres, or intra-company use, including: study protocols, investigator brochures, risk/benefit and integrated summaries from raw data (i.e., aggregate adverse event narratives), compiling, analysing and summarizing data for comprehensive study reports, tables, charts, figures, and other visual display elements for presenting clinical data Assists 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 About you: Experience: Minimum 8 years’ experience in Medical Device/Scientific Technical Writing desirable Direct experience in creating clinical-related documents for CE submission Extensive knowledge of the EU Medical Device Directive and Medical Device Regulation Knowledge, Skills and Abilities: Extensive experience in drafting EU MDR CEPs/CERs; experience with literature analysis, including managing a writing project from start to end. Medical Device experience preferred. Cross functional understanding of Design Control and Clinical Affairs. Working knowledge of adverse event reporting and international vigilance reporting. Strong project management and technical writing skills. Strong attention to detail, systematic and orientation toward careful meticulous work. Effective communicator. Able to convey messages logically and concisely. Consistently reinforces regulatory/clinical expectations and requirements. Must be proficient with MS Word Office Suite for PC, MS Excel, Adobe Acrobat XPro, MS Project, PubMed/ Embase/ Endnote. Familiarity with Agile Project Lifecycle Management. Working with CROs desirable. What we offer: You’ll receive competitive compensation and a fantastic benefits package including, bonus, 25 days holiday pension scheme, 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. HYBRID LI-JL1