Lead Engineer - Evidence Management

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Ireland R-109872, United States of America R-094794

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function:

Technology Product & Platform Management

Job Sub Function:

Agile

Job Category:

Scientific/Technology

All Job Posting Locations:

Limerick, Ireland

Job Description:

Lead Engineer, Evidence Management Digital Ecosystem

Scientific Affairs and Regulatory Affairs | Appian-first engineering and application architecture leadership

About Johnson & Johnson, MedTech

Fueled by innovation at the intersection of biology and technology, we are developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

This is primarily a hybrid role for candidates currently based within commuting distance of a Johnson & Johnson office in the United States (preferably New Jersey).  Remote candidates may also be considered on a limited basis if they hold strong credentials and required experience.

Position Summary

The Lead Engineer, Evidence Management is responsible for engineering leadership, application architecture, and delivery governance for the Evidence Management digital ecosystem spanning Scientific Affairs and Regulatory Affairs.

This is primarily an Appian-first, AI-enabled, and ecosystem-oriented engineering role. The successful candidate must bring strong hands-on and strategic experience with Appian platform architecture, Appian solution design, Appian integrations, application architecture, engineering quality practices, and SAFe delivery. Most work expectations remain primarily focused on the Regulatory Affairs domain, with Scientific Affairs included as an adjacent and expanding evidence management stakeholder group.

Mandatory Capability Requirement: Candidates will be evaluated for demonstrated ability to engineer, architect, and deliver secure, compliant, scalable solutions that create measurable business value for Regulatory Affairs and support evidence management needs across Scientific Affairs. Appian technology skills are mandatory for this position.

Role Purpose

• Serve as the Lead Engineer for evidence management capabilities covering regulatory and scientifc 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, evidence assessment, regulatory intelligence, workflow automation, post-approval activities, scientific evidence collaboration, and analytics.
• Maintain primary focus on Regulatory Affairs delivery priorities while designing solutions that can also support Scientific Affairs processes, evidence workflows, and cross-functional collaboration.
• Lead AI-enabled modernization by identifying high-value 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 to translate complex business needs into compliant, maintainable technology solutions.
• Act as the lead technical advisor for Appian application decisions, integrations, data products, engineering practices, and AI-enabled capabilities across the evidence management ecosystem.

Key Responsibilities

1. Evidence Management Application Engineering and Architecture

·       Own and maintain the application architecture strategy and engineering roadmap for evidence management capabilities across Regulatory Affairs and Scientific Affairs.

·       Design scalable, interoperable, and compliant solutions across regulatory platforms, Appian applications, data flows, workflows, integrations, content repositories, and analytics capabilities.

·       Translate complex regulatory and scientific evidence processes into practical application designs, engineering patterns, data models, and delivery backlogs.

·       Drive design governance for new capabilities, major enhancements, technical debt remediation, platform modernization, and cross-system interoperability.

·       Ensure solution designs align with enterprise standards for cloud, cybersecurity, privacy, lifecycle management, supportability, and technical sustainability.

·       Lead engineering and application architecture for Appian-based regulatory workflow, evidence case management, process automation, integration, records, reporting, and user experience capabilities and define Appian design standards

2. Evidence Management Leadership

·       Maintain deep understanding of Regulatory Affairs operating processes and technology needs across planning, submissions, regulatory intelligence, workflow orchestration, post-approval activities, content management, compliance, and analytics.

·       Ensure evidence management capabilities support traceability, auditability, role-based access, status visibility, decision history, and inspection-ready records where required.

·       Extend the evidence management architecture and engineering patterns to support Scientific Affairs use cases such as evidence intake, evidence evaluation, collaboration workflows, knowledge search, scientific content traceability, and analytics.

·       Identify common process, data, content, workflow, and integration patterns that can be reused across Scientific Affairs and Regulatory Affairs while respecting domain-specific controls.

3. Data Management and AI-enabled Evidence Management

·       Define the AI-enabled engineering roadmap for evidence management, including Generative AI, Machine Learning, NLP, semantic search, knowledge graphs, agentic workflows, and intelligent automation where appropriate.

·       Guide proof-of-concepts, pilots, and scaled implementations for AI capabilities with clear business value, security, usability, and compliance controls.

·       Establish patterns for monitoring, hallucination risk mitigation, source traceability, human-in-the-loop review, prompt/version governance, and model performance evaluation.

·       Define data architecture principles for evidence metadata, Appian data models, regulatory master data, scientific evidence content, operational data, unstructured content, and analytics-ready data products.

·       Establish engineering standards for APIs, event-driven integration, workflow orchestration, data lineage, data quality, access control, and platform interoperability.

4. Compliance, Risk and Responsible AI Governance

·       Ensure engineering and architecture decisions support GxP, SOX, privacy, cybersecurity, auditability, data integrity, validation or qualification expectations, and regulated SDLC or computerized system assurance practices.

·       Partner with Quality, Security, Privacy, Regulatory Affairs, Scientific Affairs, and Data Governance stakeholders to assess technology, Appian-specific, evidence-management-specific, and AI-specific risks.

Required Qualifications

• 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.
• Demonstrated expertise in Appian solution design, including process modeling, interfaces, records, integrations, data models, rules, reports, role-based security, application lifecycle governance, and environment management.
• Strong experience leading application engineering delivery in Agile or SAFe environments, including backlog shaping, technical design, code quality, release readiness, dependency management, and production support considerations.
• Demonstrated 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.
• Strong ability to translate business operating models, regulatory processes, and evidence management needs into scalable technical architectures and delivery-ready engineering designs.

Preferred Qualifications

• Appian certification or equivalent demonstrated enterprise Appian engineering and architecture experience.
• Experience with Regulatory Affairs platforms, RIM solutions, submission management, regulatory intelligence, regulatory analytics, content management, knowledge management systems, or evidence management platforms.
• Experience supporting Scientific Affairs, Medical Affairs, evidence generation, scientific content workflows, or knowledge search capabilities.
• Experience with Microsoft Azure AI services, Azure OpenAI, Copilot extensibility, AI Foundry, agent frameworks, or equivalent enterprise AI platforms.
• Experience applying AI in regulated environments, including human-in-the-loop workflows, validation strategy, model monitoring, data governance, and risk-based controls.
• Architecture, engineering, or Agile certifications such as TOGAF, Azure Solutions Architect, Appian certification, SAFe Architect, SAFe Agilist, or equivalent.
• Experience leading vendor technology assessments, Appian solution reviews, AI platform evaluations, proof-of-concepts, and enterprise-scale implementation planning.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

Agile Methodology, Agile Product Development, Agile Software Development, Analytics Dashboards, Change Control Management, Coaching, Critical Thinking, Diplomacy, Emotional Intelligence, Human-Computer Interaction (HCI), Organizational Design, Organizing, Program Management, Risk Management, Software Development Management, Technical Writing

The anticipated base pay range for this position is:

€71,200.00 - €123,165.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.