Support development of go to market strategy for product launches. Assist in global pricing strategies, including acquisition and SaaS modeling. Gather and analyze data to support and develop economic models. Informatics research, including market trend analysis, voice of the customer and competitive intelligence. Perform other work related duties as assigned. The Job Del

Leads, manages, and develops key competencies for FAS and ATS by co traveling with team; Actively coaches, provides professional feedback, drives best practices to meet annual objectives and developmental goals. Creates, analyzes, and reports on the team's metrics and efficiencies. Coordinates with Implementation; Schedules training time and qualify laboratories for appro

Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics a

Manage applications to the FDA for Certificates to Foreign Government (CFG), and Export Certificates. Review, approve and submit FDA invoices, FDA submission check requests and FDA forms. Manage requests for regulatory document apostilles and legalization services. Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings, holidays, lea

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

Builds financial models, formulates strategic insights, and participates in developing recommendations to drive value across Operations including capacity utilization and make vs buy as examples. Analyzes large amounts of information and data quickly and effectively to reduce complexity. Identifies issues and forms actionable recommendations with team guidance. Through ri

Provide Quality input to non conformances and product dispositions as they relate to Direct and Indirect suppliers including data analysis for potential trends. Ensure that robust investigations are performed by suppliers in a timely manor, providing strategic direction for investigations, including identification of CAPA. Implement appropriate controls around on boarding