Note: Pharma/Med Device R&D background.

Overview:
• 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.
* The ideal candidate will have the following experience:
o Implemented a new validated SaaS software vendor solution from beginning to end, including system integrations
o Led requirements gathering across many global functional teams for a new software solution
o Managed the creation and approval of the deliverables in a validation package
o Created business processes mapping to match the new software solution’s functionality and data flow
o Created the data flow through a new software solution, including upstream and downstream interfaces
o Analyzed legacy data; analyzed legacy and new data models; designed data mapping from legacy system to new system; migrated legacy data into new system
o Led the validated testing effort for a new software solution
o Collaborated with a software vendor (i.e., understanding the capabilities of the software vendor solution and identifying gaps/mitigations, resolving test defects, etc.)
o Regulatory Affairs, Regulatory Information Management

Critical Responsibilities:
* 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.)

Key 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.