Associate Director, Process Business Analyst & Documentation - Veeva Vault RIM

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Job Description

Job Title: Associate Director, Process Business Analyst & Documentation - Veeva Vault RIM

Location: Remote

Department: Regulatory Information Management (RIM) / Regulatory Operations

Position Summary

The Associate Director, Process Business Analyst & Documentation will serve as a subject matter expert in Veeva Vault RIM, with additional responsibilities in Veeva QMS coordination and system-related site development and maintenance. This role blends business analysis, technical writing, and process development to ensure regulatory information management processes are fit-for-purpose, clearly documented, and sustainable for business-as-usual (BAU) operations. A key focus will be to streamline the integration of RIM system updates into training and QMS processes, while ensuring functional alignment and ownership of controlled documents. Responsibilities will be carried out in coordination with the Head of RIM to align with strategic priorities and governance.

Key Responsibilities

Process Development & Optimization

• Partner with Regulatory Affairs and cross-functional stakeholders to design, refine, and optimize regulatory information management processes within Veeva Vault RIM.
• Facilitate process development workshops to bring together stakeholders, drive alignment, and ensure cross-functional input into new or updated processes.
• Engage with cross-functional process owners (e.g., Labeling, CMC, Compliance) to gather requirements, harmonize approaches, and ensure business needs are reflected in process design.
• Gather and analyze business requirements, translating them into structured workflows and solutions aligned with system capabilities and compliance requirements.
• Evaluate existing processes to identify gaps, inefficiencies, or risks, and recommend improvements to enhance data integrity, usability, and compliance.
• Maintain a centralized process tracker and lead weekly reviews of pending process updates to ensure priorities are clearly set, timelines are maintained, and new requests are consistently evaluated.
• Provide flexible support for strategic and ad hoc RIM initiatives, ensuring emerging priorities are addressed in alignment with business needs and organizational goals.

Process Authoring & Technical Writing

• Develop and maintain high-quality documentation, including SOPs, Work Instructions, and User Guides, that clearly communicate processes and system functionality.
• Translate complex system workflows into practical, user-friendly instructions to support adoption across global user groups.
• Ensure consistency and alignment of all authored content with business processes, regulatory requirements, and Veeva Vault RIM functionality.

System Support & Development

• Maintain and continuously improve the Veeva Vault RIM User Support site, ensuring all links, documents, and resources are accurate and up to date.
• Support system update communications by drafting clear, timely updates for users.
• Oversee the organization and version control of support materials to ensure accessibility and consistency across the user community.
• Serve as a business-side liaison with IT and system administrators, ensuring RIM enhancements and releases align with business processes and user needs.
• Conduct process impact assessments for system updates and manage related changes to documentation, processes, and training materials.

Veeva QMS Coordination & Governance

• Act as a Veeva QMS Coordi