Global Pharma Software Project Manager & Business Analyst

Insight Global

Groton (CT)

On-site

USD 110,000 - 170,000

Full time

11 days ago

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Job summary

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 role will lead end-to-end delivery of enterprise software initiatives across drug development, manufacturing, insourcing, and outsourcing operations.

This role bridges business stakeholders and technical teams, owning requirements, solution design, project execution, implementation, training, and

Qualifications

Bachelor's degree in a related field (CS/IT/Life Sciences/Pharmacy/Engineering)
5+ years of experience in software development project management
Experience in a GxP environment
Hands-on experience with SQL-based relational databases in a PM/BA capacity

Responsibilities

Lead software development projects through the full SDLC in a GxP-regulated, validated environment
Define and manage scope, timelines, budgets, risks, resources, and deliverables
Facilitate Agile/Scrum ceremonies like sprint planning, standups, retrospectives, and reviews
Collaborate with R&D, Manufacturing, Regulatory, Quality, Medical Affairs, and Commercial teams
Maintain project documentation including charters, status reports, roadmaps, requirements docs, and validation artifacts
Elicit and validate business and functional requirements (BRDs, FRDs, user stories, use cases)
Translate pharmaceutical needs into actionable technical specs for .NET teams
Support regulatory compliance and validation activities related to GxP and 21 CFR Part 11
Coordinate UAT planning, execution, and business sign-off
Develop training materials, user guides, and change management plans
Lead readiness, go-live planning, data migration, cutover, and hypercare support
Monitor post-launch KPIs and system performance