Data Architect in Regulatory
Data Architect in Regulatory
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Job Description
Job Description
Need strong resource with Enterprise Data Architect level exp.
Need to have Pharma Regulatory knowledge or background
Experienced IT Solution Architect to support systems product development in Global Regulatory Affairs.
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 for client Global Regulatory Affairs
Drive alignment to Enterprise and pharmaceutical R&D technology strategy patterns and standards!
Design maintain and socialize reference architecture patterns in collaboration with Lead Engineers.
Design maintain and socialize solution architecture collaboration with Lead Engineers.
Perform impact analysis of platform and solution changes to Regulatory applications integrations and digital workflows.
Ensure Product roadmaps align to Regulatory strategy established architectural principles and patterns and enterprise ALM/TLM requirements.
Enable business at scale through simplification of the application landscape system integration and intelligent automation.
Partner with Regulatory and Technology stakeholders to deliver and maintain architecture artifacts including tactical and strategic product roadmaps data flow diagrams reference architecture diagrams process and journey maps integration diagrams data and content architecture artifacts software engineering artifacts and security architecture diagrams. Capture architecture and design information and decisions using clientsstandard tools (Lean IX DrawIOAMTConfluenceMSTeams).
Experience and Skills Required:
BA/BS degree in a technical engineering or scientific field
AWSCertified Solutions Architect Preferred
MicrosoftCertified Azure Architect
Consolidated experience in a Solution Architect role serving the Regulatory Information Management domain.
Knowledge and skills in compute networking storage and database AWS services as well as AWS deployment and management services. Consolidated experience supporting pharmaceutical content management solutions and integration (Authoring Submissions Archival TMF Quality DAM PLM)
Consolidated experience in integration design and operationalization (REST APIs Kafka Golden Gate ETL Snowflake)
Consolidated experience architecting digital automation solutions leveraging BPM RPA NLP and ML platforms and/or services
Proven track record of designing robust highly available scalable and flexible solutions that serve a multinational user and Health Authority community.
Experience leading technical conversations workshops and work.
Experience working with Big Data Data Lakes Data products.
Experience working with GenAI Artificial Intelligence/Machine Learning High Performance Computing and Advanced Analytics on disparate data sets.
Experience working with regulated processes and systems (e.g. GxP HIPAA GDPR CSV)
Proven ability to understand and articulate business requirements direction and initiatives.
Ability to translate business strategy into technology strategy within a complex and matrixed environment.
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
Preferred:
Knowledge of RIM data and terminology
Experience with Veeva Vault and Vaultbased integrations
Experience working in a multifunctional and crossgeographic context.
Ability to context switch between multiple complex and fastmoving projects while maintaining high quality and rapid delivery.
Job Location: Raritan New Jersey (Hybrid)
Employment Type
Full Time
