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

Support monthly closing, financial reporting, and analysis Support budgeting and forecasting process Support development of business cases to provide decision support Support financial process improvements and other strategic initiatives Perform other work related duties as assigned The Individual Bachelor's or Fifth Year Master's Degree (received between December 2022 an

Support manufacturing and staff in addressing supplier related quality events for raw materials by working with suppliers to drive the identification of root cause and implementation of corrections and corrective actions while adhering to quality metric timelines. Work with engineering, product support, and quality to ensure that incoming product specifications contain an

We are seeking a qualified individual who has experience installing, operating, maintaining, repairing, and modifying electromechanical equipment, preferably in the field. Troubleshoot technical problems and systems issues. Determine technical solution in accordance with product and customer specifications and recommends actions to company or customer representatives for

Support end to end process mapping Support documentation updates and routings Track validation progress Track training progress Support data scrubbing activities Perform other work related duties as assigned The Job Deliverables The intern will present their work to a cross functional group. The Individual Required Undergraduate in Project Management, Business, Biology, L

Unloads and loads delivery trucks at multiple docks. Review and pull items needed to fill each order. Record location information in appropriate log. High level of discretion and good judgment to ensure appropriate labeling of product and supplies. Processes finished goods orders for shipment to appropriate distribution centers. Inspects products received to ensure produc

Customer Retention Maximize customer retention rates by ensuring customer satisfaction, executing pre defined customer touch point/call plan, leading customer training (on site, as needed), anticipating and defending against competitive threats, and leveraging strategic selling framework Menu Expansion Proactively team with CEM & HSE to identify and close menu expansion o

Customer Retention Maximize customer retention rates by ensuring customer satisfaction, executing pre defined customer touch point/call plan, leading customer training (on site, as needed), anticipating and defending against competitive threats, and leveraging strategic selling framework Menu Expansion Proactively team with CEM & HSE to identify and close menu expansion o

Customer Retention Maximize customer retention rates by ensuring customer satisfaction, executing pre defined customer touch point/call plan, leading customer training (on site, as needed), anticipating and defending against competitive threats, and leveraging strategic selling framework Menu Expansion Proactively team with CEM & HSE to identify and close menu expansion o

Customer Retention Maximize customer retention rates by ensuring customer satisfaction, executing pre defined customer touch point/call plan, leading customer training (on site, as needed), anticipating and defending against competitive threats, and leveraging strategic selling framework Menu Expansion Proactively team with CEM & HSE to identify and close menu expansion o

Customer Retention Maximize customer retention rates by ensuring customer satisfaction, executing pre defined customer touch point/call plan, leading customer training (on site, as needed), anticipating and defending against competitive threats, and leveraging strategic selling framework Menu Expansion Proactively team with CEM & HSE to identify and close menu expansion o

Customer Retention Maximize customer retention rates by ensuring customer satisfaction, executing pre defined customer touch point/call plan, leading customer training (on site, as needed), anticipating and defending against competitive threats, and leveraging strategic selling framework Menu Expansion Proactively team with CEM & HSE to identify and close menu expansion o

Execute manufacturing or manufacturing support processes according to standard operating procedures and current curriculum. Support schedule adjustments to meet production, material receipt and shipping requirements. Work with Shift Leader//Team Leader to review departmental production schedules, work orders and related information to ensure materials are available for pr

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