Senior Medical Writer
CooperCompanies · Trumbull, Connecticut, US
The Senior Medical Writer is responsible for developing, writing, and managing high-quality clinical and regulatory documents that support compliance and pro...
Job description
The Senior Medical Writer is responsible for developing, writing, and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards such as EU MDR and FDA regulations. This includes planning, implementing, and reporting clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials, ensuring adherence to global regulatory standards. The role collaborates cross-functionally to maintain clinical documentation within the Quality Management System and stays current with scientific literature and regulatory requirements. Experience: Preferred 5-10 years of experience in medical writing for medical devices, including CERs and PMCF documentation. Education: Master’s degree in Life Sciences or related field preferred. - Author and edit clinical documents, including Clinical Evaluation Reports (CERs), literature reviews, and regulatory submissions. - Plan and report clinical data collection for PMCF and clinical trials nationally and internationally. - Ensure clinical documentation compliance with EU MDR, FDA, and other international regulatory requirements. - Collaborate with Global Regulatory & Clin...