We offer an excellent opportunity to join our Clinical Affairs team, based in Bussolengo (Verona), as Medical Writer. \r\n\r\n In this role you will work in a team environment to help develop global evidence-based clinical strategies for orthopedic medical devices by creating clinical documentation that systematically synthesizes information from multiple data sources. \r\n\r\n You will plan and develop clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) reports, as well as a summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs. \r\n\r\n Innovation, R&D;, Regulatory & Quality, Sales & Marketing, PMO) in the company both at local and international level including relationships with US colleagues. You will also engage with external consultants, regulatory agencies and scientific organizations/companies. \r\n\r\n What will your contribution be?\r\n Reviewing medical scientific literature, analyzing clinical risk and providing benefit/risk assessment, write, review and edit CERs to comply with international regulations. \r\n Write and update coherently and convincing CERs and PMCF Reports by organizing and evaluating large amounts of scientific/clinical/medical data. \r\n Write and update CEPs and PMCF Plans. \r\n Prepare answers to the Notified Body or Regulatory Agency requests. \r\n Assist with other clinical, marketing and regulatory projects assigned. \r\n Acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices. \r\n Communicate scientific content in a clear, concise manner. \r\n Mentor and train new incoming team members about procedures and best practices. \r\n Preparing clinical collaterals in collaboration with Medical Affairs and Marketing \r\n Where necessary, involve and managing outside consultants, vendors and experts (HCP and technical experts) for the execution of the above-mentioned activities \r\n\r\n PhD is required, preferably in medical or life sciences \r\n Previous 1/3 years work experience in similar roles, preferably in innovation-oriented companies or operating in the mechanics or mechanical components sector \r\n Knowledge of ISO 14971, AIMDD, MDD, MDR, MDCG, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements. \r\n Experience with literature research, publications, and journal articles. \r\n Familiarity with citation management software. \r\n American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Medical Devices. \r\n Knowledge with Design History File, Technical File, Design Dossier, Clinical Study Report, and Clinical Evaluation Report content templates. \r\n Good English knowledge written and spoken \r\n Able to assimilate and interpret scientific content and translate information for appropriate audience. \r\n Training and development opportunities. \r\n Lavoro da remoto \r\n Social and company events. \r\n Benefits (Pension Fund – Health Insurance). \r\n\r\n Full-time permanent position.