Lead Engineer, Evidence Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

Job Function:

Technology Product & Platform Management

Job Sub Function:

Agile

Job Category:

Scientific/Technology

All Job Posting Locations:

Limerick Ireland Raritan New Jersey United States of America

Job Description:

Lead Engineer Evidence Management Digital Ecosystem

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

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 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.

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.

• 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.

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

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.

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.

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.

• 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.

• 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 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 Agile Workforce 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 :

$102000 - $175950

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 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 Additional information can be found through the link below. Experience:

Senior IC