LEAD MEDICAL WRITER - CER
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. 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
* Conduct 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 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.