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 Coordinator, ensuring system-related processes, documentation, and training records are properly managed within the Quality Management System.
• Streamline the process for tracking and implementing RIM updates into both QMS-controlled and non-QMS training materials, ensuring timely alignment with system releases.
• Consolidate current QMS processes, clarify ownership, and assign appropriate functional document owners to improve accountability and efficiency.
• Partner with Quality and Compliance teams to maintain alignment between RIM and QMS requirements.

Change Management & Training Support

• Collaborate with training teams and deliver training to ensure effective communication and delivery of process and system changes to impacted business users.
• Provide guidance on the interpretation and application of documented processes.
• Develop communication and change management strategies that promote adoption and minimize disruption during system and process changes.

Qualifications

• Bachelor’s degree in Life Sciences, Information Management, or related field; advanced degree preferred.
• 8+ years of experience in Regulatory Information Management, Regulatory Operations, or a related discipline within the pharmaceutical industry.
• Proven experience in Veeva Vault RIM, with deep knowledge of Submissions, Registrations, EDMS, and Content Planning.
• Experience with SharePoint site maintenance.
• Strong experience in technical writing (SOPs, work instructions, training guides) with the ability to simplify complex processes.
• Demonstrated strength in business analysis, including requirements gathering, process mapping, and workflow optimization.
• Experience with Veeva QMS and demonstrated ability to act as a coordinator for controlled document management.
• Strong understanding of regulatory submission and registration processes, global health authority requirements, and regulatory data standards.
• Excellent communication, facilitation, and stakeholder management skills.
• Experience leading cross-functional initiatives, with the ability to influence stakeholders across business and technical teams.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$153,600.00 - $241,340.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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