Regulatory Business Analyst

• 10+ Years of experience is mandatory.
• The Business Analyst will engage and partner with cross-functional business teams to gather business requirements, perform gap analysis, develop functional requirements, define solution recommendations, draft business cases, perform vendor research, partner with internal and external development, and testing teams to execute the projects and perform other related duties.
• The Business Analyst should be familiar with R&D operations, GxP, SDLC, Agile, and related processes.
• The candidate should have knowledge of Regulatory Affairs and will report to the Director, R&D IT.

Core Responsibilities:

• Understand and document business processes/ problems and create solutions to meet desired business outcomes.
• Lead requirements gathering efforts (Business Process/Functional and Technical Specifications).
• Establish SDLC and Agile release definitions in partnership with the business owner for concurrent initiatives. This includes identifying scope, deliverables, timelines, and leading status meetings.
• Translate and document non-technical requirements into technical requirements and design.
• Educate development teams on the proposed solution to ensure effective development cycles.
• Test the developed solutions as needed and facilitate UAT with business partners.
• Continually assess business needs and implement measures that will ensure customer expectations are met or exceeded by enhancing system capability and performance.
• Document and track change requests and facilitate prioritization discussions with IT and business owners.
• Generate meeting minutes, documentation, presentations, and reports as needed.
• Assist Project Manager as needed with project execution.
• Create training materials for solutions and deliver training to end-users.

Qualifications:

• Bachelor’s degree is required.
• Minimum 5 years of experience in the R&D Pharma IT domain and work with GxP systems.
• Minimum 2 years of Regulatory Affairs systems related work experience. 
• Project management experience is preferred.
• An understanding of systems development lifecycle deployment methodologies is required.
• Strong analytical and problem-solving skills are required.
• Proficiency using Microsoft Office (Excel, Word, PowerPoint, Visio) at an advanced level is required.
• Ability to communicate effectively with all levels of the organization.
• Up to 10% travel is required based upon business needs.