…and has a close working relationship with the Senior Director of Business and Regulatory Affairs and with the other Directors in the Business Unit (Director

…(approximately 20-25% anticipated) Preferred: US/Global experience in anti-infective clinical research, regulatory affairs , scientific and medical affairs ,

…drug development. Clear record of successfully planning and executing Medical Affairs and/or Clinical Development strategy, clinical trials, regulatory

In collaboration with the Senior Director of Regulatory Affairs , the Director of Accreditation plans, implements, directs and facilitates activities that support

…studies; work closely with a cross-functional group of experts (commercial, regulatory affairs , statistics, CMC, preclinical pharmacology, toxicology) to manage

…plans including relevant industry developments Work with project team members, regulatory affairs and senior management to integrate competitive intelligence

…Other functional groups represented on the team include project management, regulatory affairs , global clinical operations, data management, medical writing,

…assigned. Assists with study vendors selection and education. Works with Clinical and Regulatory Affairs in the preparation of project- related documents and

…in the US and the world's largest Catholic health system. The VP Medical Affairs develops strategies to align with the mission, vision and values of the

…senior subject matter expert and provides guidance in ethical foundations, compliance, regulatory affairs , relevant GCP standards, and all standards for the