Specialist, Document Systems

Position Description Nonclinical Drug Safety (NDS) Specialist in Information Management coordinates, assembles, and manages regulatory documents for internal and external nonclinical studies. Supports Preclinical Development (PCD) end user operations in Veeva and builds internal processes/tools to optimize document functions. Collaborates with NDS data scientists to establish a validatable generative-AI pipeline for authoring/reviewing draft reports. Responsibilities Contribute to report automation using advanced document management (e.g., APIs, data structures, content knowledge) to enable compliant, scalable generative-AI document generation for PCD. Build/implement/train processes and tools; act as Veeva super user/equivalent; troubleshoot issues; improve processes; support end-user training. Manage nonclinical study/supporting document generation end-to-end using document management, publishing, and project planning tools. Facilitate quality review to ensure documents are accurate, complete, and consistent with regulatory/company expectations. Collaborate with internal/external stakeholders throughout document development. Develop/implement tools and metrics to improve processes and productivity. Qualifications BS/BA in relevant sciences: 3+ years direct/relevant experience (or) MS/MA: 2+ years. Experience in nonclinical drug development programs (pharma/biotech or related). Advanced Veeva Vault operations (super/advanced user or equivalent), including process design/development and procedural controls/end-user support. Document lifecycle management (metadata, workflows, version control, records management). Some report automation experience (APIs, prompt engineering/LLMs, systems thinking, technical design/development). Preferred 2+ years in document management/ECM/regulatory platforms; Python and prompt engineering/LLM usage; business requirements translation; GxP knowledge. Benefits (if applicable) Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, 401(k), paid holidays, vacation, and sick/compassionate days. #J-18808-Ljbffr