Job Title: UDI Data Specialist
Duration: 6 months
Location: Hybrid 2-3 days a week in Bothell, WA
*Candidate must be already be located in Washington state to be considered
Overview: This UDI Data Specialist role is responsible for supporting the creation, review, update, maintenance, archiving and external publishing of product data in compliance with external global Regulatory requirements and customer expectations.
Responsibilities:
- Responsible for addressing both customer requirements regarding the datapool publishing and global Regulatory agency requirements regarding datapool standards adoption & UDI regulation.
- Perform accurate and timely data entry and maintenance, and actively manage and support continuous improvement and data integration across harmonized business system platforms.
- Proactively monitor and develop/maintain local/regional/global processes as needed for staying abreast of global Regulatory activity related to datapool standards adoption and UDI regulation and ensure compliance to all global Regulatory agency requirements for markets in which Inovio has commercialized products.
- Drive the creation, review, update, maintenance, archiving and external publishing of UDI product data to the various datapools in compliance with external global Regulatory requirements, documented policies and processes, and customer expectations.
- Ensure alignment of UDI information across labels, symbols, barcodes, and other applicable data/information.
- Resolve or escalate any data issues identified through active data quality monitoring processes.
- Effectively facilitate and manage data pool relationships including partnership management, contract administration, invoice management, data standards compliance, timeliness and comprehensiveness of external data publishing expectations and customer satisfaction.
- Complete reporting of data publishing within the Quality System according to a formal change order process.
- Effectively communicate global UDI issues, system improvements, or data requirement changes to appropriate stakeholders as needed.
- Support additional responsibilities related to Regulatory data governance, as needed.
Required Qualifications:
- Bachelor's degree
- Minimum of 2 years' experience working with UDI, GSI and/or Data Pools
- Prior experience reading, reviewing and analyzing Regulatory/Legal documents
- Demonstrated experience working on cross-functional projects and contributing to work break down structures, timeline development, prioritization management and strong organizational skills in a highly matrixed, cross functional, global environment.
- Knowledge of business process development including an understanding of data inputs/outputs, quality implications, data integrity and procedure/standards compliance
- Quantitative and analytical skills, with strong data quality focus and attention to details
- Self-directed and self-motivated with the ability to work independently, while demonstrating leadership and cooperation in team environments
- Demonstrated computer skills and systems learning aptitude, including comfort navigating through multiple applications
- Demonstrated ability to adhere to and execute against documented procedures
Desired Qualifications:
- Experience with PLM or equivalent solutions
- Experience working in a structured, regulated change management environment
- Advanced computer skills in MS Office products
