Lead Medical Writer
- Eastleigh, Hampshire
- Permanent
- Full-time
- 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
- 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.