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Bioanalytical Outsourcing Scientist Position purpose: Being responsible for the placement, monitoring and scientific review of bioanalytical studies and method development/validation at Contract Research Organizations (CROs) as well as the assurance of the quality with respect to requirements by the regulatory agencies. Preparation of documents for INDs and NDAs as well as preparing responses to regulator agencies. Key tasks: Selection of external providers for bioanalysis Proper planning with regard to timelines for all small molecule (SMOL) bioanalytical studies to be outsourced Continuously monitoring the performance of the CRO by in depth review of critical tasks; make sure to provide quality data and reports on time Establishment of bioanalytical methodology at CRO including method
