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Medasource · 3 weeks ago

Regulatory Data Translator

Raritan, NJ

Contract

Onsite

Mid, Senior Level

3+ years exp

Medasource is hiring three Regulatory Data Translators to serve as the critical link between Regulatory Strategy and their Data & AI teams. These roles are focused on translating regulatory needs into actionable data products while ensuring compliance and governance in the use of AI technologies.

Health CareMedical

Growth Opportunities

Hiring Manager

Lia Burnell

Responsibilities

Act as the primary translation layer between Regulatory Strategy and teams building data and AI products

Convert TA-specific regulatory needs into clear requirements for data product development

Communicate existing data products, AI model capabilities, and upcoming pipelines to key stakeholders, including Global Regulatory Leads

Maintain a strong understanding of regulatory “sources of truth” relevant to the assigned TA

Own AI governance activities within the assigned Therapeutic Area

Apply AI risk frameworks and conduct risk stratification for GenAI use cases in alignment with evolving FDA guidance

Ensure appropriate human-in-the-loop review for high-risk use cases impacting regulatory decisions, patient data, efficacy, or safety

Oversee the preparation of unstructured regulatory data (e.g., submissions, labels, correspondence) for LLM-enabled use cases

Ensure all AI outputs and data products are fully auditable, traceable back to source documents via metadata and vectorized text

Manage restricted regulatory data (including health authority submissions) with strict access controls and compliance standards

Qualification

Regulatory StrategyGenerative AIPharmaceutical Industry ExperienceData Product ManagementAI GovernanceStakeholder EngagementData & Technology FluencyCollaboration with IT Teams

Required

3–5 years of experience in Regulatory Strategy is required

Strong interest in data, digital, and IT-enabled innovation

Working familiarity with Generative AI concepts and real-world use cases

Proven experience collaborating with IT or data teams on solution development

Preferred

Pharmaceutical industry experience strongly preferred, with demonstrated prioritization of compliance and quality

Advanced degrees (e.g., Master's, PhD, PharmD) are preferred and common in regulatory strategy, but relevant experience is valued over specific credentials