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Clinical Evaluation Manager - Risk Manager (m/f)

Clinical Evaluation Manager - Risk Manager (m/f)

 

Clinical Evaluation Manager - Risk Manager (m/f)

 

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

  • Create and revise clinical risk management documents such as risk analyses with FMEAs as well as other documents such as clinical evaluation reports. The documents may be submitted to competent authorities as well as to communicate study data both internally and externally.
  • Coordinate/Moderate clinical risk management meetings
  • Manage the quality, accuracy and the timely production of reports
  • Perform literature searches/reviews as necessary to obtain background information for development of documents. Interfaces with clinical study managers, biostatisticians and clinical investigators
  • Interfaces with Risk management, R&D, regulatory affairs and marketing

 

Your Profile

  • MD or PhD ideally in the field of Cardiovascular Science
  • 2-3 years of experience in medical writing preferably in a similar industry including clinical study reports and protocols, as well as proven track record of publications in peer reviewed journals as 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
  • Experience with ISO 14971 and FMEAs, as well as knowledge in Risk Management is a plus.
  • Excellent command of spoken and written English and German

 

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

 

Location: Bülach | Working hours: Vollzeit  | Type of contract: Unbefristet 

Apply now under: www.biotronik.com/careers

Job ID: 27260  | Contact: Bianca Wisner  | Tel. 044 864 51 07

 

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