Specialist, Document Systems
Core
Coordinate, assemble, and manage regulatory documents for nonclinical drug safety studies, leveraging document management systems and generative AI to automate report generation.
Role type
Specialist in Information Management (Nonclinical Drug Safety)
Builds
Validatable pipelines for generative AI in authoring and reviewing draft reports; scalable document generation solutions for Preclinical Development.
Domain
Pharmaceutical/Biotechnology - Nonclinical Drug Safety & Regulatory Reporting
Deliverable
production ML models | product features
Required skills
Document lifecycle management, Veeva Vault operations, API integration, prompt engineering, LLM usage, regulatory compliance (GxP), process design, metadata management, project planning
Preferred skills
Python programming, enterprise content management, business requirements translation
Technologies
Veeva Vault, Microsoft Office Suite, APIs, LLMs, Python
Responsibilities
Manage generation of nonclinical study documents from creation to finalization; collaborate with data scientists to establish AI-driven report pipelines; troubleshoot and optimize document management tools; facilitate quality reviews for regulatory consistency; train end-users on new processes and tools.
Seniority
Mid-level, hands-on IC
