Overview
On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)
Skills
Data Analysis
Business Analysis
Data Integration
Data Quality
Lean Methodology
Master Data Management
Reference Data
RIM
Pharmaceutics
Migration
Job Details
Job Title: Data Architect, Unified Regulatory Platform
Location - Raritan, NJ (Onsite)
Job Duration: Long Term
W2 & 1099
Responsibilities:
Client is seeking an experienced Data Architect to support our Unified Regulatory Platform program working out of the NJ
Roles and Responsibilities:
- Partner with Regulatory subject matter experts, implementation and service partners, and product and platform technical owners and engineers to design scalable, extensible and supportable data architectures that drive business value in support of the Unified Regulatory Platform Strategy and Digital Transformation Strategy.
- Develop data architecture artifacts in collaboration with key stakeholders using Client standard tooling: Data Flow Diagrams, Entity Relationship Diagrams, Data Integration Artifacts, etc.
- Responsible for architecture alignment to Regulatory, R&D, Client Innovative Medicine and Client Enterprise data and data platform strategies, patterns and standards.
- Identify data that will need to be integrated across Regulatory solutions and its authoritative source.
- Advocate for data-driven decision-making by providing insights and recommendations based on data analysis and architecture principles.
- Serve as a coach to business and IT product team partners to shape strategy through sharing expertise in data governance, data quality, and data integration best practices.
- Proactively identify opportunities for leveraging data as an asset to enhance business capabilities and drive competitive advantage.
- Ability to communicate and collaborate effectively on the topics of pharmaceutical product registrations and IDMP, Regulatory submission content management, Submission Planning, Submission Publishing, Submission Archival, Labeling and Health Authority Interactions.
2025 Deliverables:
- Partner with Regulatory Data Office to define procedures and processes to harmonize, standardize and remediate data in preparation for URP migration (data cleanup/remediation in place, transformation rules on migration, etc).
- Support Regulatory product mastering efforts (including relevant reference data) map critical URP data and document objects in Lean IX and Erwin
- Develop data flow diagrams as requested (both Regulatory domain and boundary functions and processes)
- Drive alignment between URP, Regulatory, sector and enterprise governance frameworks, including policies for the creation, maintenance and stewardship of master data, reference data and critical data elements.
- Map data lineage for URP product master data and upstream and downstream relationships to other Regulatory domain and cross-domain solutions (upstream and downstream)
- Partner with the Regulatory Data Hub technical product owner and architect on ingestion and transformation/refactoring of core operational data and content coming from URP to support upstream, downstream, analytics and data science use cases going forward.
- Support critical path URP data profiling and governance requests as requested
- Support data office in helping to align emergent/overlapping data-driven initiatives (ePI/eLabeling and IDMP) to Regulatory and URP data strategy
Experience:
- 7 years experience as a data architect in Pharmaceutical R&D
- 7 years experience working with structured and unstructured data (for example, content)
- Product Master Data Management experience preferred
- Experience with Veeva Vault RIM and Vault platform APIs preferred
- Experience working with Snowflake and/or Denodo preferred
Education:
- BA/BS degree in a technical, engineering or scientific field
- AWS Data Engineer Certification (or Azure/Google Cloud Platform equivalent) preferred
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