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 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

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

Lead the team through the process of developing & translating data into insightful visualizations and interactive reports to support decision making at all levels within the business. Support the Global Operations team to make sure data needs are being met and discuss issues that need a business resolution for visualizing data or data analytics. Work with the team in buil

Characterizes and optimizes manufacturing processes for yield, quality, and product performance Leads teams in troubleshooting and problem solving efforts related to product performance Design and develop processes to reduce variability within the product, improve operating capabilities, and help ensure safety. Champions new technologies and influences department strategy

Performs and documents QC Testing of WIP Production Lots and special evaluation assignments Supports daily QC Chemistry core functions as needed Performs and documents final QC Testing Supports new product development/improvement projects Performs general housekeeping and laboratory organization Carries out duties in compliance with established business policies Works and

Ownership of global S&OP process Manage forecasting, planning, and inventory control processes globally Optimize global inventory levels to meet customer service, business continuity, and cost objectives throughout the global distribution network linking suppliers, customers, distributors, and warehouses. Coordinates global supply chain product availability, issues, and p

Manage delivery of MDM engagement using Agile or Waterfall methodologies Develop highly performant, reliable, and scalable MDM and Data Governance solutions for Customer, Product etc. Coach and develop team members to overcome technological challenges Communicate with business, IT and other entities to understand data ecosystem, business requirements and be able to transl

Coordinate changes to ensure that the integrity of the live environment is protected and that the correct components are released. Ensuring that all IT teams follow the incident/problem management process for all major occurrences and document any repeated non conformity. Monitor batch services, identifying Anomalies and support batch service requests Maintenance of chang

Support Ortho's current Information Technology controls (based on NIST, SOX, HIPAA, PCI DSS, ISO 27001/2, and Internal Technology security standards) as well as regulatory Technology Compliance for countries that Ortho operates in by conducting periodic Technology/Security Compliance assessments to identify deficiencies and provide guidance as to current industry best pra

Partner with internal resources to independently assess, identify and monitor business drivers influencing financial results. Responsible for the global consolidation of a highly visible segment of the Company's business. Responsible for planning, executing, and interpreting this segment's forecasting process. Improve the overall reporting process by coordinating the effo

Manage S&OP, planning, and inventory control processes for the hub distribution centers. Optimize inventory levels to meet customer service, business continuity, and cost objectives throughout the distribution network linking suppliers, customers, distributors, and warehouses. Coordinates product availability, issue management and resolution, working with all appropriate

Manages Repair parts planning through detailed analytics and alignment with cross functional stakeholders in order to meet profitability targets. Manages projects related to product launches, discontinuances, service improvement, inventory and other supply chain initiatives. Supports the Spares business through the Sales and Operations Planning process. Ensures key perfor

Performs and documents QC Sofia Testing of WIP Production Lots and special evaluation assignments. Support daily QC Chemistry core functions as needed. Performs and documents 1st article functional Sofia Final Kit QC Testing. Support new Sofia product development/improvement projects. General housekeeping and laboratory organization. Carries out duties in compliance with