Solution Architect, Regulatory

4 weeks ago

New Brunswick, United States CareerBuilder Full time

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 J&J-standard tools (Lean IX, Draw-IO, AMT, Confluence, MS Teams)

Education:

BA/BS degree in a technical, engineering or scientific field

AWS-Certified Solutions Architect Preferred

Microsoft-Certified Azure Architect

Requirements
Must have

5+ years of experience in a Solution Architect role serving the Regulatory Information Management domain.

Knowledge and skills in computer networking, storage and database AWS services as well as AWS deployment and management services

7+ years of experience supporting Pharmaceutical content management solutions and integration (Authoring, Submissions, Archival, TMF, Quality, DAM, PLM)

5 years of experience in integration design and operationalization (REST APIs, Kafka, Golden Gate, ETL, Snowflake)

3-5 years of 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 multi-national 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.

Strives to remove ambiguity, drive consensus and reach decisions across stakeholders.

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

A Plus

Knowledge of RIM data and terminology

Experience with Veeva Vault and Vault-based integrations

Experience working in a multi-functional and cross-geographic context.

Ability to context switch between multiple complex and fast-moving projects while maintaining high quality and rapid delivery.

Other:

20% Travel

Has to be in the office and client sit

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