Software Development PM/BA

Insight Global is seeking a Software Development Project Manager / Business Analyst to support a global pharmaceutical client within their External Development and Manufacturing Solutions group. This individual will lead the end-to-end delivery of enterprise software initiatives supporting critical business functions across drug development, manufacturing, insourcing, and outsourcing operations., Lead software development projects through the full SDLC within a GxP-regulated and validated systems environment.

• Define and manage project scope, timelines, budgets, risks, resources, and deliverables.
• Facilitate Agile/Scrum ceremonies including sprint planning, standups, retrospectives, and reviews.
• Partner with cross-functional stakeholders across R&D, Manufacturing, Regulatory, Quality, Medical Affairs, and Commercial teams.
• Maintain key project documentation including charters, status reports, roadmaps, requirements documentation, and validation artifacts.
• Elicit, document, and validate business and functional requirements, including BRDs, FRDs, user stories, use cases, process flows, and acceptance criteria.
• Translate complex pharmaceutical business needs into actionable technical specifications for .NET development teams.
• Support regulatory compliance and validation activities related to GxP, 21 CFR Part 11, validated systems, and applicable quality processes.
• Coordinate UAT planning, execution, and formal business sign-off.
• Develop training materials, user guides, job aids, and change management plans to support global adoption.
• Lead implementation readiness, go-live planning, data migration coordination, cutover planning, and hypercare support.
• Monitor post-launch KPIs, adoption metrics, system performance, and continuous improvement opportunities.

This role will serve as the bridge between business stakeholders and technical teams, owning requirements gathering, solution design, project execution, implementation, training, and post-launch support. The ideal candidate will bring a strong blend of project management, business analysis, technical understanding, and experience working in GxP-regulated, validated systems environments., Bachelor’s degree in Computer Science, Information Technology, Life Sciences, Pharmacy, Engineering, or related field required

• 3+ years of experience in software development project management and/or business analysis, with at least 2 years in the pharmaceutical, biotech, or medical device industry
• Demonstrated experience delivering enterprise projects on the .NET stack within GxP-regulated environments
• Hands-on experience with SQL-based relational databases in a project or BA capacity
• Proven track record managing CSV (Computer System Validation) projects and working within quality management systems

Nice to Have Skills & Experience

• Master’s degree, MBA, or advanced degree in a life sciences discipline preferred
• PMP (Project Management Professional)
• PMI-ACP or CSM (Agile/Scrum)
• CBAP or PMI-PBA (Business Analysis)

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.