- Develop, revise and review clinical strategies/ clinical evaluation plans, clinical evaluation reports, PMCF plans and reports, summaries of safety and clinical performance and clinical investigator brochures. The documents are submitted to regulatory authorities and notified bodies
- Manage the quality, accuracy, and timely production of reports/ plans
- Perform literature searches/reviews as necessary to obtain and maintain up to date knowledge for the development of documents and for providing subject matter expertise to other departments
- Support risk management activities like development and maintenance of product risk analyses and benefit-risk assessments
- Act as a core team member for product development projects
- Interfaces with risk management, R&D, regulatory affairs, study managers, biostatisticians and marketing
- MD or PhD ideally in the field of Cardiovascular Science
- 2-5 years of experience in medical writing preferably in a similar industry including clinical study reports and protocols, as well as a proven track record of publications in peer reviewed journals as the main author
- Excellent presentation and moderation skills, including technical editing and QC skills
- Good understanding of statistics, together with the ability to interpret complex clinical data
- Team oriented, accurate and self-dependent personality with an analytical working style
- Knowledge of MEDDEV rev. 4 and MDR
- Experience with ISO 14971 and FMEAs, as well as knowledge in Risk Management is a plus
- Excellent command of spoken and written English, German is an advantage
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Clinical Evaluation Manager - Bülach, Schweiz - BIOTRONIK
Beschreibung
Clinical Evaluation Manager %)
As one of the world ́s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.
The Medical Affairs Group is responsible for the design, conduction and evaluation of international first-in-man, regulatory submission and post-marketing trials.
Your Responsibilities
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