Specialist, Document Systems

Position Overview

In the dynamic environment of Nonclinical Drug Safety (NDS), a Specialist in Information Management works with internal scientific staff and across our Research & Development Division to coordinate, assemble, and manage regulatory documents for internal studies and those acquired from external efforts. Using technical skills in document management, publishing, and other tools, the Specialist will support Preclinical Development (PCD) end‑user operations in Veeva and development of internal processes and tools to optimize document functions.

The successful candidate will collaborate closely with NDS data scientists to establish a new, validatable pipeline to leverage generative AI in authoring and reviewing draft reports across the NDS portfolio.

• Actively contribute to report automation efforts by using advanced document management systems skills (e.g. APIs, data structures, and document / content knowledge). Bring strong process and systems thinking to drive business integration and enable scalable solutions that facilitate the effective and compliant use of generative AI in document generation in PCD.
• Collaborate with appropriate specialists to build, implement, and train users on related processes and tools for cross‑functional participation. Utilize advanced document management skills (e.g. Veeva super user or equivalent skills) to troubleshoot and resolve issues and recommend process and functionality improvements. Contribute to the training and skills development of end‑users.
• Manage the generation of nonclinical study and supporting documents from creation through to finalization through careful oversight of required processes, content development & review, and document integration.
• Facilitate quality review to ensure that documents are appropriate, complete, and consistent with regulatory and company expectations.
• Careful collaboration with internal and external stakeholders throughout the document development and related processes.
• Participate in the development and implementation of tools and metrics to understand and improve processes and productivity.

• BS/BA degree in biological, chemical, computer science, and/or medical science disciplines with a minimum of 3 years direct and relevant experience, or
• MS/MA degree in the same disciplines with a minimum of 2 years direct and relevant experience.

• Experience supporting nonclinical drug development programs within the pharmaceutical, biotechnology, or related industry.
• Direct, advanced experience with Veeva Vault operations and functions (e.g. super/advanced user, system owner, or equivalent); experience including process design / development, generation of procedural controls, and/or end‑user support.
• Strong understanding of document lifecycle management, metadata, workflows, version control, and records management principles.
• Some experience with report automation functions and technology (e.g. API calls, data, prompt engineering, strong LLM usage, systems thinking, technical design, development, operation, implementation, business integration).
• Experience with standard document publishing tools.
• Proven ability to review, revise, and prepare high‑quality documents with accuracy and consistency.
• Excellent leadership, written and verbal communication skills (including a strong command of English grammar, editing, and proofreading).
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and other business‑related computer systems and software applications.
• Demonstrated exceptional attention to detail with a strong commitment to accuracy, quality, and compliance.

• 2+ years of experience supporting document management systems, scientific platforms, enterprise content management, or regulated business applications.
• Experience with Python, prompt engineering, strong LLM usage a plus.
• Experience gathering business requirements and translating them into technology solutions.
• Solid understanding of applicable GxP regulations.

• API calls, automation tools, content editing, content management,…