Solution Architect

Solution Architect, Regulatory Strategy

Roles and Responsibilities:

·       Partner with Product teams, Technology Services, Data Scientists and other architects to design scalable, flexible and supportable technical systems that drive business value in support of Global Regulatory Affairs

·       Develop architecture artifacts in collaboration with business and JJT product owners, business and technical SMEs, data scientists, platform owners and product engineers, as well as Information Security, Quality and Technology Services stakeholders.

·       Artifacts for each project include the business context diagram, process overview, data flow diagram, application architecture, data model overview, integration architecture, infrastructure architecture and overviews of workflow orchestration and agentic orchestration within the solution.

·       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-tenant platforms, 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 large document 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 and terminology. Experience with medical writing and authoring processes and technologies will also be 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, data pipeline 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, Google Cloud Platform and/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, database and integrations
• Proficiency in frameworks such as TensorFlow, PyTorch, or similar tools for incorporating generative 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 security management 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 the audience effectively)
• Experience leading technical conversations, working to remove ambiguity, drive consensus and decisions 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 transform complex topics into concise architectural diagrams and presentations.
• Strong ability to build and manage relationships at various levels, both inside and outside an organization.
• Proven track record of designing robust, highly available, scalable and flexible solutions that serve a multi-national user and Health Authority community.