Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application. Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures. Documents audit observations and makes recommendations for corrective and preventive action. May create and maintain clinical quality assurance databases, reports, and files. Performs quality reviews and tracks corrective and preventive actions until closure. May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements. May also audit operating systems, processes and procedures. May support risk
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