PRD2 Business Integrator

Keywords Studios•Indianapolis, IN

5d•$78

About The Position

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.

Requirements

Bachelor’s degree in one of the following fields:
- Supply Chain Management
- Business Administration,
- Information Systems,
- Data Analytics,
- Engineering or a related technical specialty
Technical Tools: Excel, Power BI, Visio, Access Database.
Core Competencies: Data analysis, process mapping, regulatory compliance, documentation management, collaboration site development.
Soft Skills: Attention to detail, problem-solving, cross-functional communication, ability to manage multiple priorities.

Nice To Haves

Certifications in Power BI, Excel Advanced, or Database Management are a plus.

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.