Requires a Bachelors degree in a life sciences related discipline such as Chemistry, Pharmaceutical Science, Regulatory Affairs or related field or foreign equivalent and three 3 years of regulatory and startup activities for clinical trials and post marketing clinical studies experience. In lieu of a Bachelors degree, employer will accept a High School diploma and seven 7 years of regulatory and startup activities for clinical trials and post marketing clinical studies experience. Requires experience to include three 3 years informed consent form development and country ICFs review against country specificities; development and reviewing of regulatory authorities and Institutional Review Boards submission packages; communication with regulatory authorities and institutional review boards; following clinical trials SOPs consistently; and working on several projects like clinical trial and noninterventional studies concurrently while retaining quality and timelines. Requires 510 domestic and international travel to attend meetings and KOM conferences.
Categories: eb3
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