Job Description: The Team As the Director of Quality Management, you are accountable for the execution of the organizations quality audit efforts and are responsible for providing oversight of the Quality Management System and business unit-wide projects and initiatives.
Job Purpose/ Summary: Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with,
Job Purpose/ Summary: The Director, Model Informed Drug Development/ Consulting is a senior individual contributor responsible for leading modeling and simulation activities within drug development programs. The incumbent applies advanced pharmacometric methodologies to support dose selection,