Medasense Biometrics is seeking for a Medical Scientific Liaison
Medasense is a medical technology company in the field of pain. Medasense has developed a proprietary technology platform, which identify and grades the individual physiological response to pain- spearheading pain management towards personalized care. Medasense’s technology enables clinicians to optimize the pain treatment and by that, minimize adverse events, improve clinical outcomes and reduce costs.
As a Medical Science Liaison (MSL) the main purpose of the role will be to build partnerships with external healthcare professionals, to communicate evidence based critical scientific, technical and development issues relating to company products and the therapeutic areas they relate to.
Duties and Responsibilities
• Assume overall responsibility for establishment and management of clinical studies including: study protocol (CRFs, ICF), agreements, investigator brochure and all other necessary documentation for study initiation.
• Ensure clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations (ISO 14155, GCP regulations, 21 CFR).
• Support clinical sites with preparation and submission of required documentation to Institutional Review Boards. Ensures maintenance of IRB approval throughout the duration of the study, and ensures compliance with national and international regulations.
• Provide training to clinical sites regarding protocol requirements and data collection.
• Conduct periodic site monitoring visits. Verifies data accuracy and perform data entry/verification as part of data management.
• Provide clinical status reports in compliance with federal reporting requirements to regulatory agencies, IRBs, Investigators and senior management.
• Support Regulatory Affairs with regulatory filings/registrations when necessary, such as but not limited to development of clinical reports for 510(k)s/PMAs as applicable, and clinical expertise related to FDA submission questions.
• Support in scientific and marketing publications.
• Develop and maintain professional relationships with clinical sites to provide comprehensive clinical support.
Working hours: Full time job. Office location is in Ramat Gan. Overseas travel 30-40%
Reports to: Clinical Trial Manager
Interface with: R&D, Clinical and Marketing
• 5 years’ experience in the medical device industry
• Strong knowledge of GCP and other regulatory requirements
• Excellent oral and written English language skills
• Bsc./M.Sc. in life science/medical science/Bio Medical engineer
• Good analytical skills
• Ability to interface scientifically, gain support and communicate with different levels of clinicians.
• Ability to manage multiple projects and adapt priorities according to business and strategic needs.
Please submit your resume to: email@example.com