Lead Engineer, Evidence Management

Johnson & Johnson

. Serve as Lead Engineer for evidence management capabilities covering regulatory and scientific workflow, case management, process automation, content/data flows, integrations, and user experience .

Posted 10/26/2026full-timeRaritan • New Jersey • United StatesSenior💰 $102,000 - $175,950 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Appian application architecture and engineering, with a strong focus on regulatory and scientific workflows, AI-enabled solutions, and compliance with industry standards. Proven ability to lead cross-functional collaboration and design scalable, interoperable systems in regulated environments.

Highest-signal resume keywords

Appian Application ArchitectureAI-Enabled Solutions EngineeringRegulatory Affairs ComplianceAgile Delivery MethodologiesData Architecture Principles

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Hard Skills

Software EngineeringApplication ArchitectureSolution ArchitectureProcess ModelingData ModelingIntegrationsGenerative AIMachine LearningAPI DevelopmentWorkflow Automation

Soft Skills

Cross-Functional CollaborationTechnical LeadershipProblem SolvingCommunication

Tools & Technologies

Appian PlatformMicrosoft Azure AI ServicesLarge Language ModelsSemantic SearchVector DatabasesAI Observability

Certifications & Qualifications

Appian CertificationAgile CertificationsArchitecture Certifications

Industry Keywords

Regulatory AffairsScientific AffairsGxPSOXData IntegrityRegulated SDLCEvidence ManagementClinical TechnologySafety TechnologyLife Sciences

Tech Stack

Tools & technologies

AzureCloudCyber SecuritySDLC

About the role

Key responsibilities & impact

Serve as Lead Engineer for evidence management capabilities covering regulatory and scientific workflow, case management, process automation, content/data flows, integrations, and user experience
Define and guide application architecture for platforms supporting regulatory planning, submissions, evidence intake and assessment, regulatory intelligence, workflow automation, post-approval activities, scientific evidence collaboration, and analytics
Maintain primary focus on Regulatory Affairs while designing solutions supporting Scientific Affairs processes and cross-functional collaboration
Lead AI-enabled modernization by identifying evidence management use cases, designing scalable implementation patterns, and ensuring responsible adoption in regulated environments
Partner with Regulatory Affairs, Scientific Affairs, Quality, R&D, Supply Chain, Cybersecurity, Privacy, Data Governance, and IT delivery teams
Act as lead technical advisor for Appian application decisions, integrations, data products, engineering practices, and AI-enabled capabilities
Own and maintain the application architecture strategy and engineering roadmap
Design scalable, interoperable, and compliant solutions across regulatory platforms, Appian applications, data flows, workflows, integrations, content repositories, and analytics
Translate regulatory and scientific evidence processes into application designs, engineering patterns, data models, and delivery backlogs
Drive design governance for new capabilities, enhancements, technical debt remediation, platform modernization, and cross-system interoperability
Ensure solutions align with enterprise standards for cloud, cybersecurity, privacy, lifecycle management, supportability, and technical sustainability
Lead Appian-based regulatory workflow, evidence case management, process automation, integration, records, reporting, and user experience capabilities
Ensure traceability, auditability, role-based access, status visibility, decision history, and inspection-ready records
Define AI-enabled engineering roadmap covering Generative AI, Machine Learning, NLP, semantic search, knowledge graphs, agentic workflows, and intelligent automation
Guide AI proofs-of-concept, pilots, and scaled implementations with security, usability, and compliance controls
Establish controls for hallucination risk mitigation, source traceability, human-in-the-loop review, prompt/version governance, and model performance evaluation
Define data architecture principles and engineering standards for APIs, event-driven integration, workflow orchestration, data lineage, data quality, access control, and platform interoperability
Ensure compliance with GxP, SOX, privacy, cybersecurity, auditability, data integrity, validation or qualification, and regulated SDLC practices
Partner with Quality, Security, Privacy, Regulatory Affairs, Scientific Affairs, and Data Governance stakeholders on technology and AI risk assessment

Requirements

What you’ll need

Bachelor degree in Computer Science, Engineering, Information Systems, Data Science, AI/ML, or a related field
10+ years of progressive experience in software engineering, application architecture, solution architecture, platform architecture, low-code platform architecture, data architecture, or enterprise technology delivery
Mandatory hands-on experience engineering, architecting, and delivering solutions on the Appian platform
Expertise in Appian solution design, including process modeling, interfaces, records, integrations, data models, rules, reports, role-based security, application lifecycle governance, and environment management
Experience leading application engineering delivery in Agile or SAFe environments
Experience with backlog shaping, technical design, code quality, release readiness, dependency management, and production support considerations
Experience architecting or engineering AI-enabled enterprise solutions, including Generative AI and/or Machine Learning use cases
Hands-on knowledge of Large Language Models, prompt engineering, semantic search, vector databases, Retrieval-Augmented Generation, model orchestration, AI observability, and responsible AI controls
Experience designing secure, cloud-native, API-enabled, workflow-enabled, and data-centric platforms in complex enterprise environments
Experience supporting regulated business functions such as Regulatory Affairs, Scientific Affairs, Quality, Clinical, Safety, R&D, or Life Sciences technology
Working knowledge of GxP, SOX, privacy, cybersecurity, data integrity, regulated SDLC, validation, qualification, or computerized system assurance practices
Ability to translate business operating models, regulatory processes, and evidence management needs into scalable technical architectures and delivery-ready engineering designs
Appian certification or equivalent demonstrated enterprise Appian engineering and architecture experience preferred
Experience with Regulatory Affairs platforms, RIM solutions, submission management, regulatory intelligence, regulatory analytics, content management, knowledge management systems, or evidence management platforms preferred
Experience supporting Scientific Affairs, Medical Affairs, evidence generation, scientific content workflows, or knowledge search capabilities preferred
Experience with Microsoft Azure AI services, Azure OpenAI, Copilot extensibility, AI Foundry, agent frameworks, or equivalent enterprise AI platforms preferred
Experience applying AI in regulated environments preferred
Architecture, engineering, or Agile certifications preferred
Experience leading vendor technology assessments, Appian solution reviews, AI platform evaluations, proof-of-concepts, and enterprise-scale implementation planning preferred

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member; 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Inclusive interview process and disability accommodations