Justin Fuentes - Consultant Resume Simple
SUMMARY
I am a highly motivated, detail oriented, and dedicated professional with over 10 years of experience in the pharmaceutical industry. I have a strong background in the field of pharmacy.
SKILLS
  • medical devices, therapeutic, ich, fda, medical, drug development
  • medical devices, therapeutic, ich, fda, medical, drug development
WORK EXPERIENCES
  • 2017-12-252017-12-25

    Consultant

    Net Results Sports Center

    • Responsible for the development of the project management Plan, and the implementation of the clinical trial. I have also developed and implemented a comprehensive and ongoing training program for the clinical research team.
    • Developed and maintained medical device budgets and ICH guidelines for FDA and EU health regulations. Conducted audits of the company.
    • Contributed to the development of a new FDA 510(K) submission for the cardiovascular disease. Wrote the protocols for the device.
  • 2017-12-252017-12-25

    Associate Consultant

    Anritsu Company

    • Development of study protocols, informed consent forms, case report forms, and clinical trial management plan. Review and approve regulatory documents for submission to the FDA.
    • Ensured that all regulatory documents are in compliance with FDA, ICH, GCPs, and other applicable regulations governing the medical device and the FDA.
    • Developed and implemented a new protocol for the FDA submission for the drug and device trial. I was also involved in the development of the IND safety reports.

  

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