Essential duties and responsibilities:
As a Clinical Writer you will be responsible for compiling the clinical documentations, preparing a scientific conclusion on the safety and performance of client’s products throughout the entire product lifecycle in compliance with regulatory requirements (EU MDR, FDA).
• Designing and conducting systematic literature searches;
• Identifying, appraising, and analyzing all relevant (clinical, PMS, marketing, and testing data) from multiple sources and creating a comprehensive scientific review;
• Writing clinical evaluation plans and reports (CEP and CER);
• Compiling Post-Market Surveillance (PMS) documentation, e.g., PMS reports / Periodic Safety Update Report (PSUR) / Summary of Safety and Clinical Performance (SSCP) / PMCF plans and reports;
• In addition, you be supporting our marketing department with reviewing promotional materials and training slide decks. You will ensure accuracy and consistency across all clinical content.
You will be part of the Regulatory team, working with RA professionals (Head of Quality and Regulatory Affairs, RA Manager, Sr. Regulatory Affairs Expert, QA/RA Officers) which is part of a larger QA/RA department.
Skills and abilities desired:
• You have advanced degree in chemistry, (medical) biology, biomedical technology, or similar;
• 3+ years of working experience with writing (scientific) documents and proven knowledge of medical (device) terminology;
• Knowledge of global Medical Device Regulations (EU MDR, FDA, TGA, etc.), particularly in relation to generating and evaluating clinical data of medical devices;
• Direct experience with writing clear, high-quality clinical documentations;
• Experience and drive for continually learning to use state of the art MS-Office productivity tools, database applications and eDocument Creation / Management tools (e.g. eQMS, eReport Generators);
• Pragmatic, accurate, analytical, enjoying the dynamics of dealing with several stakeholders, business processes, regulatory and clinical challenges;
• Strong organizational skills, detail-oriented to deal with different projects at the same time;
• Must be able to work well independently, as well as being able to work cooperatively in a team of professionals;
• Fluent in English, both verbally and in writing.