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Job Details

Job Description

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/or Performance Evaluation Reports for CE technical documentation in accordance with the requirements of the EU Medical Device Regulations (MDR) and/or EU In Vitro Diagnostics Regulations (IVDR) and/or Clinical Risk-Benifit Assessment Reports (CRBA) and related guidance documents (e.g. MEDDEV.2.7./1 Rev. 4). This involves analyzing available safety and performance data for medical devices/in vitro diagnostics and preparing clinical data documents that support regulatory submissions for the EU, US, and other international markets.

The Senior Medical Writer also assists with writing and reviewing regulatory documents related to the preparation, conduct and reporting of clinical investigations and other PMCF/PMPF activities.

Responsibilities

• Creation and maintenance of regulatory documents related to clinical data of Haemonetics products (CEP/PEP; CER/PER; PMCF/PMPF;SRV; CPR; LSR; CRBA) in liaison with other departments
• Plan and execute structured literature searches, identify and analyze relevant clinical data
• Write Clinical Evaluation and Performance Evaluation plans and reports in compliance with applicable regulatory requirements (EU MDR, EU IVDR, MEDDEV 2.7/1, MDCG guidance documents)
• Write 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

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/ In Vitro Diagnostics/pharmaceutical industry. 5 yrs in medical/scientific writing
• Manage numerous external vendors and/or 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, other EU language is a plus

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