Lead Medical Writer - CER in Southampton

LennTech are working with a global medical device client who have an exciting opening for an experienced Medical Writer to lead a team of three. The ideal person will provide expertise on regulatory gap closures, conduct clinical-related technical writing for medical device regulatory projects (CER, MDD/ MDR compliant format, literature review and analysis) and support clinical projects including study reports and manuscripts.

Key Duties

• 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.
• 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.
• 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 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.
• 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.
• 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 client is considered the Sponsor.

Experience

• Minimum 5 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.
• 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.
• Familiarity with Agile Project Lifecycle Management.