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Lead Business Analyst with FDA (closed)

New Jersey
DOE/hr compensation
Contract Employment
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Job Description

Lead Business Analyst with FDA

Mahwah, NJ

12 months contract


The Lead Business Analyst is responsible for supporting the current UDI program team at customer to facilitate the design, implementation, and support of multiple technology solutions to ensure customer can comply with the new federal UDI legislation.


Ensure the UDI program delivers within the FDA required timeline to ensure compliance with new regulations

Other deliverables as assigned


Partner with Key business stakeholders;

  • Translate FDA UDI regulations into business and technical requirements for customer Corporation
  • Leads user requirement gathering sessions/meetings.
  • Works closely with Business users and SME to facilitate these sessions.
  • Complete alll documentation assigned in the timelines assigned
  • Partner with IT Project managers and IT Business Analysts assinged to the UDI program to ensure high level UDI business and technical requirements are leveraged.


  • Ensure consistency and compliance across the entire program.
  • Identify opportunities for process optimization, process redesign, or development of new process/solution


  • Continuous review of program track documentation
  • Identify gaps between teams
  • Identify gaps from established requirements
  • Resolve all gaps between teams in a timely manner
  • Development of all necessary system documentation, Testing Strategies, and Test Plan in collaboration with the Testing Manager and Solution Architect


  • Continued coordination with the Program Manager
  • Reporting on timeline, deliverables
  • Issues, Risks
  • Status Reports



  • BS or BA degree or equivalent
  • 2+ years of experience in a Lead business analyst role; driving collaboration across IT BA’s and key business stakeholders
  • 6+ years of experience business analysis type role where interaction with the business partners and documenting functional expectations was achieved
  • 4+ years’ experience designing and implementing complex business solutions
  • Previous experience in regulated environments, i.e. Pharmaceuticals, Medical Device
  • Knowledge of various Enterprise systems and applications including but not limited to ERP (Oracle, JDE, PRMS) PLM (Agile, PTC)
  • Experience in large scale IT program implementation; design, implementing, deployment and validation enterprise software system compliant in an FDA environment.
  • Ability to develop strong relationships with stakeholders and customers
  • Strong communication, problem solving and team leadership skills. Ability to accept and process customer feedback.
  • Strong customer service orientation
  • Works as a collaborative part of the program team in a fast-paced and ever changing environment
  • Exceptional written, verbal and presentation skills to a diverse set of audiences
  • Excellent planning, organizational, and problem solving skills.
  • Ability to work under time constraints to meet deadlines
  • Ability to manage and prioritize workloads
  • Ability to successfully execute Project management methodologies, tools and skills.
  • Utilizes proper software and technological tools to maintain proper records including and not limited to a PPM system, Visio, Excel, Word, SharePoint, and PowerPoint Willing to travel up to 30%


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