The Dignify Solutions, LLC
Solution Architect with Pharma & Regulatory Experience - Onsite
The Dignify Solutions, LLC, Raritan, New Jersey, us, 08869
Solution Architect with Pharma & Regulatory Experience - Onsite
3 weeks ago Be among the first 25 applicants
Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance.
Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases.
Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways.
Design and optimize Cloud-native data pipelines for regulatory data ingestion, transformation, and analytics (e.g., using Azure, AWS, or GCP).
Provide thought leadership on emerging technologies (e.g., AI/ML, LLMs, NLP) and their relevance to the evolving regulatory landscape.
Lead or support integration of external partner systems and health authority interfaces (e.g., EMA, FDA, PMDA).
Work closely with Data Governance teams to ensure master data and metadata management align with IDMP and xEVMPD standards.
Seniority level Mid-Senior level
Employment type Full-time
Job function Other
Industries IT Services and IT Consulting
#J-18808-Ljbffr
Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance.
Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases.
Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways.
Design and optimize Cloud-native data pipelines for regulatory data ingestion, transformation, and analytics (e.g., using Azure, AWS, or GCP).
Provide thought leadership on emerging technologies (e.g., AI/ML, LLMs, NLP) and their relevance to the evolving regulatory landscape.
Lead or support integration of external partner systems and health authority interfaces (e.g., EMA, FDA, PMDA).
Work closely with Data Governance teams to ensure master data and metadata management align with IDMP and xEVMPD standards.
Seniority level Mid-Senior level
Employment type Full-time
Job function Other
Industries IT Services and IT Consulting
#J-18808-Ljbffr