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Medical Affairs Lead

2 months ago

Indianola, Pennsylvania, United States Bayer Full time
Job Summary

Bayer is seeking a highly skilled Medical Affairs Lead - Medical Device Operations to join our team. As a key member of our global medical device operations team, you will be responsible for providing medical and scientific expertise to support the development and commercialization of our medical device portfolio.

Key Responsibilities
  • Lead the creation, support, and management of notified body related medical affairs activities, including CERs, PMCF, PSURs, etc.
  • Consolidate existing medical-scientific expertise and activities between global product experts.
  • Complete evidence gap identification and support publication planning and opinion leader development with relevant product teams and stakeholders.
  • Improve dialogue, information exchange, and alignment between global/regions/countries.
  • Member and medical lead for device development projects/studies within Product Squads.
  • Co-develop educational materials and content for both internal and external stakeholders.
  • Ongoing lifecycle support for license to market.
  • Co-Lead risk assessment for devices and provide health risk assessments (HRA) as required.
  • Lead/support aspects of global projects and adapt product offerings to critical industry trends and competitive activity with support from senior MA medical device/SaMD leaders.
  • Contribute to the continued execution of medical affairs as an industry-leading organization.
Requirements
  • Advanced Degree with clinical experience or a Bioscience/engineering degree with relevant experience in the medical device area.
  • Relevant experience with medical device development.
  • Deep knowledge in FDA, EU, ICH, and Notified Bodies guidelines, initiatives, and regulations governing medical devices & SaMD.
  • Medical device experience supporting the creation of educational content.
  • Ability to support the development of studies and build evidence generation plans.
  • Strong communication and interpersonal skills and the ability to drive measurable outcomes with virtual teams.
  • Desire and ability to work in a fast-growing, agile business environment.
  • Willing to travel internationally to global meetings and international congresses.
  • Good medical writing skills and ability to analyze safety data.
  • Good communication skills.
  • Fluent in English, both written and spoken.
Preferred Qualifications
  • Medical qualification as MD or equivalent (D.O., M.B.B.S, etc.), preferred.
  • 2-3+ years industry experience.
  • Exposure to artificial intelligence/machine learning applications in Radiology is a plus.