We are seeking an experienced Solution Architect to support Regulatory Strategy projects from the site in Raritan, NJ. The Regulatory Strategy Product Group delivers solutions which drive process orchestration, intelligent automation, advanced analytics and predictive modelling for Global Regulatory Affairs in Innovative Medicine.
Roles and Responsibilities:
Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value in support of Regulatory Strategy and Intelligence
Develop architecture artifacts in collaboration with business and client product owners, lead engineers, platform owners, R&D Architecture, 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 ML and ML Ops architectures.
Responsible for architecture alignment to Regulatory, Enterprise and R&D technology strategies, patterns, standards and design principles.
Enable business at scale through simplification of the application landscape, system integration and intelligent automation.
Capture architecture and design information and decisions using Clients-standard tools (Lean IX, SAXpress, Asset Management, Draw-IO, AMT, Confluence, MS Teams)
Education:
BA/BS degree in a technical, engineering or scientific field
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
Experience architecting regulated systems (GxP, HIPAA, GDPR, etc)
2-3 years of experience architecting digital automation solutions using BPM, RPA, NLP and ML
Infrastructure engineering experience covering computer, networking, storage, database and AWS machine learning services as well as AWS deployment and management services.
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 supporting the development of 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.