Medasource · 21 hours ago
Regulatory Data Strategist
Raritan, NJ
Contract
Onsite
Mid, Senior Level
3+ years expMedasource is seeking three highly specialized Regulatory Data Translators to bridge Regulatory Strategy and Data and AI teams. This role focuses on ensuring regulatory compliance and robust AI governance while translating complex regulatory data needs into actionable data products for high-priority Therapeutic Areas such as Oncology, Immunology, and Neurology.
Health CareMedical
Hiring Manager
Landan Chastain
Responsibilities
Serve as the translating layer between the regulatory strategy function and the internal teams building data products and capabilities
Connect the TA’s specific data needs directly to the personnel responsible for building the necessary data products
Effectively communicate the features of existing data products, the capabilities of already built AI models, and upcoming data development pipelines to key stakeholders, including Global Regulatory Leads
Maintain comprehensive knowledge of the sources of truth for regulatory data pertinent to the assigned TA
Own and manage AI governance within the assigned Therapeutic Area
Implement risk frameworks by conducting risk stratification for all Gen AI use cases, aligning with recent FDA guidance on AI governance
Ensure that high-risk use cases—those affecting regulatory decisions, patient-related data, efficacy, or safety—incorporate a human-in-the-loop reviewer to maintain appropriate oversight
Oversee the transformation of unstructured regulatory data, including submission archives, labels, and correspondence, to prepare it for LLM capabilities
Ensure that LLM outputs and data products support a complete audit trail back to the source documents (labels, correspondence, and health authority submissions). This involves working with vectorized text and associated metadata tags to guarantee traceability
Manage the handling of restricted data, such as all submissions to health authorities, ensuring strict access control and compliance standards are maintained
Qualification
Required
3–5 years of experience in Regulatory Strategy is essential, balancing foundational knowledge with enthusiasm for hands-on, AI-focused work
Demonstrated passion for data and IT-driven topics
Familiarity with the application of Generative AI (GenAI) concepts and practical AI use cases
Must have history collaborating with IT teams and some experience with solution building, although this is not a data science role
Preferred
Experience in the Pharma industry is strongly preferred, demonstrating a proven prioritization of compliance over speed
Prior experience as a North America regulatory lead for Oncology, Immunology, or Neurology would be ideal
Advanced degrees (such as Master's, PhD, or PharmD) are common for regulatory strategists and preferred, but demonstrated experience is prioritized over a specific degree
Company
Medasource
Medasource is a hospital & health care company specializing in population health management and clinical engineering services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Abimbola ojo
EPIC OPTIME/ ANESTHESIA Consultant at Ascension
Company data provided by crunchbase