Head Of Project Management Services
CurrentDynamic, methodical team leader with over 30 years of Project Management experience. Created the Program Management Office for regulatory information management transformation. Successfully implemented an international validated product registration and life-cycle management system. Provides program road-maps, RAID, scope management, project reporting structure, identification of deliverables and milestones, status reports, stakeholder communications, meeting cadences, and leadership updates.Projects include drug substance and drug product campaigns. FDA and EU regulatory: IND, IMPD, NDA, and BLA filings. Coordinate multiple disciplines include drug substance, analytical, drug product, quality assurance, regulatory, and supply chain. Manage Client-CMO relationships, and track progress, budget, and deliverables.
