What are the responsibilities and job description for the IT Business Analyst, UDI position at GForce Life Sciences?
Consultant, UDI Business Analyst, Medical DeviceSummary
Our client, a multinational pharmaceutical and medtech company, has engaged GForce Life Sciences to provide aUDI Business Analyst.Thisposition will report to a Technical Director. This role willfacilitate and lead the product delivery team & regional deployment teams through the planning, definition, pipeline management, oversight & acceptance of delivery of UDI-related development.Duties / Expectations of Role
Our client, a multinational pharmaceutical and medtech company, has engaged GForce Life Sciences to provide aUDI Business Analyst.Thisposition will report to a Technical Director. This role willfacilitate and lead the product delivery team & regional deployment teams through the planning, definition, pipeline management, oversight & acceptance of delivery of UDI-related development.Duties / Expectations of Role
- Expected to manage effective communication with internal partners and customers across Medical Devices and Pharma business segments concerning product releases
- Assist internal customers to stay in sync with requirements during regulation releases & new UDI product releases, with a focus on new regulations as they are released by individual Health Authorities
- Drive requirements definition and compliance delivery to ensure key milestones are met in support of regional regulatory compliance & the Global UDI Data strategy
- Support regional Analysts with deployment-based business support as needed.
- Knowledge of IT systems and SDLC process
- Support base business work and project management, lead User Acceptance Testing
- Work with Franchise business users to capture input to user requirements
- Customer SDLC, Standard Operating Procedure, Work Instruction and other Quality & Compliance document development and approval
- Support design team as technology solution is designed
- 10 years of Business and IT experience combined.
- 5 - 7 years of progressive experience as a Business Analyst
- UDI Implementation Experience and understanding of the regulations
- A demonstrated ability in the creation of user requirements, design documents, and test scripts
- Experience in gathering requirements and business analysis
- Experience with system development and regulatory aspect
- IT knowledge and experience
- 5 years of project management experience
- 4 years’ experience working in Pharma/medical device industry
- 3 years of direct experience with RUP, regulated systems, and documentation
- Requires an in-depth knowledge of the system development life cycle
Term & Start
- 9 months
- ASAP
- Full time
- Local toNJ
- Benefits included (Medical, Dental, Vision, 401k)