The Program Manager's role is to effectively oversee/manage multiple projects comprising a program within the specified time frame and budget per EPMO Policies and Procedures, including use of the Banks Project Life Cycle, and project management tools/methodology.
Responsible for continuous evaluation of drug safety profile, including the aspects of relevance to patients in clinical studies, as well as external stake holders (e.g., health authorities) with support from Drug Safety & Epidemiology.
The director will develop opportunities and execute efforts that sustain and grow the companys engineering, manufacturing, product development, testing, process optimization and energetics research capabilities through understanding client needs, technical challenges, and ability to develop solutions to meet technical requirements.
Develops and maintains processes and procedures to manage risks and ensures appropriate ownership. Accountable to first line management of first line programs, second line1 programs, and regulatory exam activities.
In this role, you oversees assigned program including: vendor management, operational workflows, process improvement, operational excellence, designing & applying performance metrics, contact centers, reimbursement distribution and specialty pharmacy operations, and managing associated budgets.
Responsibilities will include leading and managing the Launch Readiness operational activities, including developing and maintaining high performing teams, ensuring alignment between project and program strategies and plans, generating high quality global strategic integrated project plans, risk management and communication plans.
this role will lead cross-functional teams from multiple Integra sites, and external partners, to support development and manufacturing of innovative medical device products and/or devices that are integrated with biologics to create combination drug/device products.
Lead launch readiness process (LREx) and champion its execution at global and local level.Manage of day-to-day budget and monitor performance across the Sotagliflozin GBT, ensuring cost effective, impact and delivery of all programs.