Specialist, Document Systems

About the role

The Specialist in Information Management plays a crucial role in coordinating, assembling, and managing regulatory documents for internal studies and those obtained from external efforts within the Nonclinical Drug Safety (NDS) division. They work closely with internal scientific staff and across the Research & Development Division to support Preclinical Development (PCD) end user operations in Veeva and develop internal processes and tools to optimize document functions.

Responsibilities

• Contribute to report automation efforts by utilizing advanced document management systems skills such as 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 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) 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.
• Collaborate 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.

Qualifications

• Required: BS/BA degree in biological, chemical, computer science, or medical science disciplines OR MS/MA degree in the same fields - Minimum 3 years direct and relevant experience OR 2 years direct and relevant experience.
• Experience supporting nonclinical drug development programs within the pharmaceutical, biotechnology, or related industry.
• Advanced experience with Veeva Vault operations and functions (e.g. super / advanced user, system owner, or equivalent).
• Strong understanding of document lifecycle management, metadata, workflows, version control, and records management principles.
• 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, etc.).
• Experience with standard document publishing tools.
• Prominent ability to review, revise, and prepare high-quality documents with accuracy and consistency.
• Excellent leadership skills, 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.

Skills

• API Calls, Automation Tools, Content Editing, Content Management, Detail-Oriented, Document Lifecycle Management, Document Management, Document Management Tools, Drug Development, GxP Regulations, Information Management, LLM Evaluation, Metadata, Microsoft Office, Professional Proofreading, Project Document Management, Project Management Planning, Project Planning, Proofreading, Python (Programming Language), Regulatory Affairs Management, Regulatory Compliance, Regulatory Reporting, Regulatory Submissions

Benefits

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.