This position requires a Bachelors degree or foreign equivalent in Health Sciences, Regulatory Affairs for Drugs, Biologics, and Medical Devices or a related field plus 10 years of postbaccalaureate experience in a GCP clinical trial function showing demonstrable ability in the skill set described above. 10 years of postbaccalaureate experience should include a minimum of 5 years of experience in technical GCP auditing. The auditing experience must encompass conducting GCP site, vendor and system audits as well as managing inspection readiness and health authority inspections.
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