Position: UDI Analyst
Location: Horsham, PA
Duration: Full Time with benefits
“Technical skills in particular with data analysis and troubleshooting/critical thinking skills. Ideally having someone with an IT background would help fill in for some of the IT work that the business team has adopted over the last year from our IT group; including compliance analysis, requirements gathering, system troubleshooting, and systems documentation updates.”
Position located in Horsham, PA location. There may be some meetings that require travel to the Bridgewater or Piscataway locations.
This role will be part of the project team supporting new regulations and requirements in the EU, UK, South Korea, India, and China. Candidate will also assist this team in providing support for the US FDA regulation.
- Provide support for users of existing system, including:
- Help desk support, including monitoring mailbox and working with users to address issues with UDI systems.
- User management, including training of new users, ensuring new users have completed appropriate training and have appropriate authorization, and leading periodic reviews of user permissions.
- Work with Organization Change Management and key subject matter experts to create new training and update existing training as needed. Maintain latest training in Client online training environment.
- Standards Development
- Work with project managers / directors / regulatory affairs to document (and maintain) global requirements in a standard format.
- Project Administration / Coordination:
- Provide project support to project managers / directors through ownership of documentation and key dashboards / metrics.
- Assistance as needed with facilitation of meetings, including notes and follow ups.
- Lead meetings as needed, working closely with users as needed.
- Assist in development and management of key project documentation (work plan, resource management, budget).
- Help create and maintain an online system, providing access to key documents and metrics within Sharepoint sites.
- System Development
- Participate as business team member, assisting in the definition of business requirements.
- Assist in the development of key system documentation, including user requirements and test scripts.
- Participate in the testing of new releases.
- Tools and knowledge
- Experience with projects that include both a process component and a technology component
- Knowledge of MS Office applications: Word, Excel, and Powerpoint
- Experience with data analytics / visualization is a major plus (Tableau)
- Experience with system development and deployment
- Experience with system testing and documentation