Solution Architect-Regulatory Strategy and Data Architect-Regulatory Strategy

Solution Architect-Regulatory Strategy and Data Architect-Regulatory Strategy

Position 1: Data Architect – Regulatory Strategy

Responsibilities:- Partner with Regulatory subject matter experts, development partners, product technical owners and engineers, Technology Services, Data Sciences and fellow Pharma architects to design scalable, extensible and supportable data architectures that drive business value in support of Regulatory Strategy and Intelligence.- Develop data architecture artifacts in collaboration with key stakeholders using standard tooling: Data Flow Diagrams, Entity Relationship Diagrams, Data Integration Artifacts, etc.- Responsible for the architectural alignment of Regulatory data products with Regulatory, R&D, Innovative Medicine and Enterprise data and data platform strategies, defining and leveraging proven patterns and standards.- Regularly engage with key business leaders and technical teams to pilot and leverage standard platforms to drive data quality, standardization and interoperability in support of Regulatory Strategy and cross-domain initiatives, including product master data alignment and interoperability, ontology management, graph/RAG and cataloging capabilities to form a semantic layer to drive contextualization and speed to value of Regulatory data assets.- Develop and maintain conceptual, logical and physical data models associated with Regulatory Strategy solutions.- Assist in the development of a data governance framework that includes policies for the creation, maintenance and stewardship of master data, and critical data elements.- Collaborate with business stakeholders to gather and translate their data needs into functional and technical architecture.- Advocate for data-driven decision-making by providing insights and recommendations based on data analysis and architecture principles.- Address and resolve conflicts arising from diverse business unit requirements, ensuring smooth integration of stakeholder needs.- Serve as a coach to the Regulatory Data Office, Data Sciences and Technology product team partners to shape strategy through sharing expertise in data governance, data quality, and data integration practices.- Proactively identify opportunities for leveraging Regulatory data and contents as an asset to enhance business capabilities and drive competitive advantage.

Required Skills:- BA/BS degree in a technical, engineering or scientific field.- AWS Data Engineer Certification (or Azure/GCP equivalent).- Experience with Snowflake and Denodo preferred.- AWS Well-Architected Framework certification preferred.- AWS Certified Machine Learning Specialty certification preferred.- 2+ years developing content vectorization and graph/RAG strategies in support of generative AI initiatives. --- Position 2: Solution Architect – Regulatory Strategy

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 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 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.

Required Skills:- 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).- 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, GCP and/or Azure for data capture, advanced 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. Other:- 10% Travel.