Regulatory Strategy Solution Architect

Solution Architect, Regulatory StrategyRoles and Responsibilities: Partner with Product teams, Technology Services, Data Scientists and other architects to designscalable, flexible and supportable technical systems that drive business value in support ofGlobal Regulatory Affairs Develop architecture artifacts in collaboration with business and JJT product owners, businessand technical SMEs, data scientists, platform owners and product engineers, as well asInformation Security, Quality and Technology Services stakeholders. Artifacts for each project include the business context diagram, process overview, data flowdiagram, application architecture, data model overview, integration architecture, infrastructurearchitecture and overviews of workflow orchestration and agentic orchestration within thesolution. Responsible for architecture alignment to Regulatory, R&D and Innovative Medicine technology strategies, patterns and standards. Enable business at scale through scalable technologies, containerized applications, multi-tenantplatforms, reusable integration patterns and intelligent automation. Capture architecture and design information and decisions using J&J-standard tools (Lean IX, SAXpress, Asset Management, Draw-IO, AMT, Confluence, MS Teams, Cloverpop) Architecting generative and agentic solutions trained on both structured data and largedocument corpora in the authoring of controlled documents.Education: BA/BS degree in a technical, engineering, data sciences or scientific field AWS-Certified Solutions Architect certification required AWS Well-Architected Framework certification desirable Microsoft Azure Solutions Architect certification required One or more IaaS machine learning certification programs (ML/genAI/agentic AI)

Experience and Skills:Required: Understanding of Pharmaceutical Regulatory Affairs domain, capabilities, data, content andterminology. Experience with medical writing and authoring processes and technologies will alsobe considered. 5+ years of experience as a Solution Architect in Pharmaceutical development 5+ years of experience in integration design and operationalization (REST APIs, Kafka, ETL, datapipeline design, API gateways, data streaming). 5+ years of experience working with content management platforms and structured RDBMS 5+ years experience architecting and deploying cloud-native, scalable solutions on AWS, GCPand/or Azure for data capture, advance analytics and intelligent automation. Experience architecting regulated systems (GxP, HIPAA, GDPR, etc). Experience architecting workflow automation solutions leveraging generative AI and/or machine learning to deliver operational efficiencies. Cloud native solution engineering experience covering compute, networking, storage, databaseand integrations. Proficiency in frameworks such as TensorFlow, PyTorch, or similar tools for incorporatinggenerative AI models and capabilities into agentic, workflow automation and analytic solutions Understanding of large language models (LLMs), their training, and fine-tuning. Knowledge of model training, evaluation, optimization and data privacy and securitymanagement when leveraging public LLMs Ability to tackle complex business challenges and provide actionable AI-based solutions. Strong written and verbal communication skills (ability to communicate in the language of theaudience effectively) Experience leading technical conversations, working to remove ambiguity, drive consensus anddecisions across stakeholders Proven ability to understand and articulate business requirements, direction, and initiatives Experience surfacing technical requirements and contributing to IT product roadmaps Excellent oral and written communication skills including the ability to translate and transformcomplex topics into concise architectural diagrams and presentations. Strong ability to build and manage relationships at various levels, both inside and outside anorganization. Proven track record of designing robust, highly available, scalable and flexible solutions thatserve a multi-national user and Health Authority community.