Lead Engineer, Evidence Management
Johnson & Johnson
September 03, 2026
Remote friendly (Raritan, NJ)
United States
IT
Lead Engineer, Evidence Management Digital Ecosystem (Appian-first, AI-enabled). Hybrid role (commute to US office, preferably New Jersey); remote candidates may be considered.
Position Summary
- Lead engineering, application architecture, and delivery governance for the Evidence Management digital ecosystem spanning Scientific Affairs and Regulatory Affairs.
- Focus on Regulatory Affairs delivery priorities with Scientific Affairs as an adjacent/expanding stakeholder area.
Role Purpose
- Lead evidence management capabilities: regulatory/scientific workflows, case management, process automation, content/data flows, integrations, and UX.
- Define and guide application architecture for regulatory planning/submissions, evidence intake/assessment, regulatory intelligence, post-approval activities, collaboration, and analytics.
- Modernize evidence management with AI-enabled modernization in regulated environments.
- Partner with cross-functional teams to deliver compliant, maintainable solutions.
- Serve as lead technical advisor for Appian decisions, integrations, data products, engineering practices, and AI capabilities.
Key Responsibilities
- Own architecture strategy/roadmap; design scalable, interoperable, compliant Appian/regulatory platform solutions.
- Translate complex regulatory/scientific processes into application designs, patterns, data models, and backlogs.
- Governance for enhancements, technical debt, modernization, and interoperability.
- Ensure traceability, auditability, role-based access, status visibility, decision history, inspection-ready records.
- Define AI-enabled engineering roadmap (GenAI/ML, NLP, semantic search, knowledge graphs, agentic workflows/automation) with responsible AI controls.
- Establish engineering standards (APIs, event-driven integration, orchestration, data lineage/quality, access control, interoperability).
- Ensure decisions support GxP, SOX, privacy, cybersecurity, auditability, data integrity, validation/qualification/computerized system assurance.
Required Qualifications
- Bachelor’s in CS/Engineering/IS/Data Science/AI-ML or related field.
- 10+ years in software/application/solution/platform architecture or enterprise technology delivery.
- Mandatory hands-on Appian engineering, architecture, and delivery.
- Expertise in Appian solution design (process modeling, interfaces, records, integrations, data models, rules, reports, RBAC, lifecycle governance, environment management).
- Experience leading Agile/SAFe delivery.
- Experience architecting/engineering AI-enabled enterprise solutions (GenAI/ML).
- Hands-on LLMs, prompt engineering, semantic search, vector DBs, RAG, orchestration, AI observability, responsible AI controls.
- Experience designing secure, cloud-native, API- and workflow-enabled data-centric platforms.
- Experience with regulated functions (Regulatory Affairs/Scientific Affairs/Quality/Clinical/Safety/R&D/Life Sciences).
- Working knowledge of GxP, SOX, privacy, cybersecurity, data integrity, regulated SDLC, validation/qualification, computerized system assurance.
Preferred Qualifications
- Appian certification; Regulatory Affairs/Sci Affairs/evidence or RIM platform experience.
- Azure AI services (Azure OpenAI/Copilot extensibility/AI Foundry) and AI platforms.
- AI in regulated environments (human-in-the-loop, validation strategy, monitoring, governance, risk controls).
- Relevant architecture/engineering/Agile certifications (TOGAF, Azure Solutions Architect, SAFe Architect/Agilist) and vendor assessments/AI platform evaluations.
Application Instructions
- Apply to the role(s) for Raritan, NJ or Limerick, Ireland; applications for multiple requisitions are considered as a single submission.
Position Summary
- Lead engineering, application architecture, and delivery governance for the Evidence Management digital ecosystem spanning Scientific Affairs and Regulatory Affairs.
- Focus on Regulatory Affairs delivery priorities with Scientific Affairs as an adjacent/expanding stakeholder area.
Role Purpose
- Lead evidence management capabilities: regulatory/scientific workflows, case management, process automation, content/data flows, integrations, and UX.
- Define and guide application architecture for regulatory planning/submissions, evidence intake/assessment, regulatory intelligence, post-approval activities, collaboration, and analytics.
- Modernize evidence management with AI-enabled modernization in regulated environments.
- Partner with cross-functional teams to deliver compliant, maintainable solutions.
- Serve as lead technical advisor for Appian decisions, integrations, data products, engineering practices, and AI capabilities.
Key Responsibilities
- Own architecture strategy/roadmap; design scalable, interoperable, compliant Appian/regulatory platform solutions.
- Translate complex regulatory/scientific processes into application designs, patterns, data models, and backlogs.
- Governance for enhancements, technical debt, modernization, and interoperability.
- Ensure traceability, auditability, role-based access, status visibility, decision history, inspection-ready records.
- Define AI-enabled engineering roadmap (GenAI/ML, NLP, semantic search, knowledge graphs, agentic workflows/automation) with responsible AI controls.
- Establish engineering standards (APIs, event-driven integration, orchestration, data lineage/quality, access control, interoperability).
- Ensure decisions support GxP, SOX, privacy, cybersecurity, auditability, data integrity, validation/qualification/computerized system assurance.
Required Qualifications
- Bachelor’s in CS/Engineering/IS/Data Science/AI-ML or related field.
- 10+ years in software/application/solution/platform architecture or enterprise technology delivery.
- Mandatory hands-on Appian engineering, architecture, and delivery.
- Expertise in Appian solution design (process modeling, interfaces, records, integrations, data models, rules, reports, RBAC, lifecycle governance, environment management).
- Experience leading Agile/SAFe delivery.
- Experience architecting/engineering AI-enabled enterprise solutions (GenAI/ML).
- Hands-on LLMs, prompt engineering, semantic search, vector DBs, RAG, orchestration, AI observability, responsible AI controls.
- Experience designing secure, cloud-native, API- and workflow-enabled data-centric platforms.
- Experience with regulated functions (Regulatory Affairs/Scientific Affairs/Quality/Clinical/Safety/R&D/Life Sciences).
- Working knowledge of GxP, SOX, privacy, cybersecurity, data integrity, regulated SDLC, validation/qualification, computerized system assurance.
Preferred Qualifications
- Appian certification; Regulatory Affairs/Sci Affairs/evidence or RIM platform experience.
- Azure AI services (Azure OpenAI/Copilot extensibility/AI Foundry) and AI platforms.
- AI in regulated environments (human-in-the-loop, validation strategy, monitoring, governance, risk controls).
- Relevant architecture/engineering/Agile certifications (TOGAF, Azure Solutions Architect, SAFe Architect/Agilist) and vendor assessments/AI platform evaluations.
Application Instructions
- Apply to the role(s) for Raritan, NJ or Limerick, Ireland; applications for multiple requisitions are considered as a single submission.