Hybrid Senior Manager, Clinical Science, Medical Affairs

Posted 4 weeks ago

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About the role

  • Provide scientific expertise for clinical studies and evaluations in the TMTT division
  • Independently author complex documents including clinical protocols and reports
  • Conduct literature reviews from initiation to completion
  • Review raw and summary clinical data for accuracy
  • Analyze safety and effectiveness results from clinical trials
  • Collaborate with cross-functional teams on study results

Requirements

  • Bachelor's Degree in a related field with 10 years of related experience in clinical science or medical/scientific writing; OR Master's degree with 8 years of related experience; OR Doctorate degree with 8 years of related experience
  • Familiarity with coronary interventional and/or structural heart environments
  • Experience in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations
  • Experience with FDA PMA applications
  • Strong knowledge of scientific research methodology, GCP, ICH guidelines and Global regulations
  • Experience in a cross-functional environment, collaborating with various specialists
  • Excellent communication skills and experience influencing stakeholders
  • Expert knowledge of regulatory requirements and clinical study execution

Benefits

  • COVID Vaccination Requirement: proof of vaccination required for healthcare roles
  • Equal Opportunity/Affirmative Action employer

Job title

Senior Manager, Clinical Science, Medical Affairs

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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