Project Management Documentation Regulatory Compliance
Team Management Audits Performance Assessment
飪� Supporting the selection and evaluation of new proposed CROs for BA/BE studies on factors such as compliance to the regulatory requirements, facility, resources and infrastructure of CROs.
飪� Completing the outsourced BA/BE projects on time at CROs as per specified timelines and with compliance.
飪� Filing of BA/BE study reports received from various CROs and ensuring proper documentation.
飪� Ensuring adherence to set timelines, plans, GLP norms and regulatory requirements (e.g. ICH, EDQM, US FDA) at current CROs by analyzing and monitoring bio-analytical activities...
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