PRD2 Business Integrator

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.

•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.

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

KeyWords provides all its contingent workforce with:

• Medical, dental and vision benefits
• Paid time off (including sick and select holidays)
• 401(k) enrollment with 3% employer matching

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

Role Information: EN
Studio: Keywords Studios
Location: Indianapolis, IN

Area of Work: Business Integrator
Service: Manufacturing
Employment Type: Contractor
Working Pattern: Full Time

This Organization Participates in E-Verify

Keywords Studios is committed to fair and ethical hiring practices. We expect candidates to conduct themselves with honesty and to participate in all applications and interviews independently, presenting their own knowledge and experience. Candidates should refrain from using AI assistance or third-party tools or services that could influence, capture, or otherwise interfere with the authenticity of the assessment process.