Location: Indianapolis, Indiana

Pay Rate: 78k+/Salary DOE

The PRD2 Business Integrator serves as a key liaison between business processes and technical solutions, ensuring seamless integration of data, tools, and workflows to support regulatory, inventory, and supply chain operations.

This role focuses on automation, process optimization, and compliance support, leveraging advanced tools such as Excel, Power BI, Visio, and Access to enhance efficiency and accuracy across global operations.

Key Responsibilities:

Data Automation & Reporting:

- Automate recurring reports using Excel and Power BI.

- Design inventory and forecasting tools that translate complex data into clear, actionable graphics.

Process Mapping & Documentation

- Refine existing process maps in Visio, incorporating hyperlinks to business processes, white papers, and external regulatory resources.

- Prepare documentation for specific requests using standardized templates and deliver to country representatives for expanded access programs.

Database Management

- Maintain a database of previously calculated item country valuations.

- Develop and manage an Access Database system to store valuation information for imports.

- Track and maintain metrics for monthly country valuations completed and requests processed.

Regulatory & Compliance Support

- Support TCOE Regulatory technical initiatives, including:

▪Reviewing regulatory repositories

▪Recommending repository consolidation.

▪Developing a combined regulatory repository.

- Upload documents into Regulus and ensure shipment documentation completeness in collaboration with Quality Assurance.

Collaboration & Site Development

- Gather user requirements for TCOE collaboration site development.

- Design and implement site features to improve usability and compliance tracking.

Order & Shipment Coordination

- Follow up on orders to ensure timely processing and delivery.

- Maintain shipment request logs for expanded access programs, including:

▪Request dates.

▪Regulatory application numbers.

▪Shipment and patient status.