Develops, coordinates, and administers an effective compliance training program to ensure that all appropriate employees and management are knowledgeable of, and comply with, pertinent laws and regulations.
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies.
Develop health economics and outcomes research (HEOR) strategic approaches for product(s), while maintaining in-depth knowledge of disease state, market and customer dynamics, and reimbursement issues.
Lead development and implementation of Oncology market and patient based forecast models & tracking; proactively identify new data sources/methodologies that will enhance decision making & increase forecast accuracy.
Responsible for process development and manufacture of drug substances under cGMP conditions; Responsible for vendor management, including vendor selection, technology transfer, and cGMP API manufacturing.
Assist the Senior Director, Enterprise Applications in the development of statements of work, contracts, managed service and service level agreements with vendors, and strategic sourcing related to the area of focus.