Director of R&D Data Science leading regulatory data products at Johnson & Johnson. Developing AI-ready products and ensuring compliance with global regulatory standards.
Responsibilities
Lead a team to define and deliver data products addressing critical Global Regulatory Affairs use cases.
Define and maintain a roadmap for Global Regulatory Affairs data products, spanning pre-submission activities through post-market surveillance.
Develop data products through agile delivery and FAIR data principles.
Integrate internal and external Global Regulatory Affairs data sources.
Contribute to the development and governance of a Global Regulatory Affairs Ontology.
Partner with Knowledge Management, Data Product Architecture & Governance, and Master Data Management teams.
Lead a cross-functional team of product owners, data engineers, and Global Regulatory Affairs domain experts.
Define and track KPIs to measure the impact of data products on submission timelines.
Requirements
PhD or Master's in informatics, computer science, life sciences, or related discipline.
8+ years of experience in pharma/biotech R&D with a focus on Global Regulatory Affairs, regulatory operations, regulatory technology, or data product management.
Strong track record in data product development, integration, or semantic modelling in a regulated domain.
Experience working with multi-modal regulatory data, including submission, labeling, intelligence, and compliance datasets.
Benefits
medical, dental, vision, life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Job title
Director, R&D Data Science, Data Products – Global Regulatory Affairs
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