Job Description :
RIM experience is a must. RIM – Regulatory Information Management
Business Analyst/ Validation Tester
Duration: 12+ month contract
Location: Deerfield, IL
Duties and Responsibilities:
This is an IT business analyst role on the R&D IT team, supporting the Regulatory Affairs, Global Patient Safety, Medical Affairs and Clinical Affairs portfolio of projects.
This role will be an IT business analyst on a large global project to implement a validated Regulatory Information Management (RIM) suite SaaS vendor solution and necessary system integrations to existing systems, as well as migrate legacy data into the new RIM solution.
Lead business functional requirements, technical requirements and solution delivery on enterprise/large projects within the R&D IT function.
Gather, understand and document business objectives, requirements, functional specifications through workshops/interviews/meetings.
Manage the creation and approval of the deliverables in a validation package
Identify, evaluate, develop and /or redesign systems and procedures that meet user requirements.
Define, design and document business flows and processes for large, highly complex projects.
Understand interdependencies of systems for multiple businesses or functions. Provide cross-functional and business knowledge to develop business system and process alternatives.
Design data flow through software solutions, including upstream and downstream interfaces
Use technical tools (queries, process maps, etc for problem resolution.
Conduct data analysis; design business rules for data accuracy and consistency; design data mapping and data migration. Identify and resolve data quality issues.
Establish validation test strategy; develop and execute test cases; lead validation testing with IT and business partners; manage defects with software vendors and IT.
Assist in development of training materials and/or conduct training.
Provide support on R&D business applications.
Understand and follow appropriate SDLC, quality validation processes and application processes.
Communicate status, solutions and concerns.
Disseminate information in a timely manner within the team and across functions.
Make decisions that have a cross-functional or business impact and analyze financial impact.
Collaborate with software vendors (i.e., understand capabilities of software vendor solution and identify gaps/mitigations, resolve issues, etc
Qualifications:
Bachelor''s degree in Information Technology
8+ years of business analysis experience and implementing IT solutions
Prefer 3+ years of regulatory affairs and/or regulatory information management experience
Demonstrate strong business acumen, solution delivery expertise and a strong understanding of systems for both on-premise and SaaS offerings
Proven success (3+ years) managing large project requirements highly desired
Ability to accomplish results through others, utilizing effective influencing and leadership skills
Must be able to solve complex business problems and present recommendations to senior management effectively
Must be able to define, shape, and drive projects to completion while effectively collaborating with others
Experience working on all SDLC business processes: requirements, design, development, testing, training and deployment
Experience working with third-party external teams in the support and implementation of IT solutions
Data analysis and data migration experience
Require limited direction; give significant direction; detail and quality oriented; possess extensive knowledge of policies, standards and procedures; have excellent presentation, communication, teamwork and interpersonal skills.
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