We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details This position is responsible for the creation of scientific and regulatory documents while working with a cross-functional team in accordance with the highest quality standards. The Senior Medical Writer is responsible for performing, preparing, and maintaining Clinical Evaluation Reports and PMCF documentation for CE technical documentation in accordance with the requirements of the EU Medical Device Regulations (MDR) and related guidance documents (e.g. MEDDEV.2.7./1 Rev. 4). This involves analyzing available safety and performance data for medical devices and preparing clinical data documents that support regulatory submissions for the EU, US, and other international markets. Importantly, the Medical Writer also assists with generating clinical documents, and compiling and reviewing cross-functional input (e.g., PMS data, customer surveys) prepare and readout on PMCF activities, including the generation of PMCF plans and reports. Responsibilities Creation and maintenance of regulatory documents related to clinical data of Haemonetics products (CER, SSCP, PMCF) in liaison with other departments Plan and execute structured literature searches, identify and analyze relevant clinical data Write Clinical Evaluation plans and reports in compliance with applicable regulatory requirements (EU MDR, MEDDEV 2.7/1, MDCG) Write PMCF plans, protocols and reports; work with Project Management to manage cross-functional stakeholders and review and integrate their input into PMCF plans and reports Write study protocols, safety plans and reports in liaison with Medical and Regulatory Affairs Support Medical Affairs and Regulatory Affairs in development and execution of regulatory strategies Manage vendors; Plan and coordinate vendor activities Manage temporary worker staff (1-2 people over time) Required qualifications Bachelor or Master of Science (required) or higher graduate degree (preferred) Minimum of 7-10 years of experience in in the medical device/pharmaceutical industry 5 Minimum years of experience in medical/scientific writing Manage numerous external vendors and contingent workers (supervisory role) Clear, concise scientific style of writing; attention to detail to provide high-quality results Affinity to scientific literature and data analyses using state-of-art information technology Basic knowledge of biostatistics and medical background/application of Haemonetics products Organized and self-driven; project management skills to manage multi-product writing portfolio Excellent English language skills, German or other EU language is a plus EEO Policy Statement Conditions of Employment: Haemonetics’ policy requires COVID-19 vaccination for all U.S. employees, unless approved for a medical, religious or business exemption. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, our customers and our communities as we continue to make health and safety our top priority.