Business Analyst III, Provider Billing
Centene Corporation
SQL
Associate Director, Process Business Analyst – Veeva Vault RIM
Takeda
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $153,600 - $241,340 per year
Job Level
Senior
Tech Stack
Vault
About the role
- 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 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.
- 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.
- 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.
- Conduct process impact assessments for system updates and manage related changes to documentation, processes, and training materials.
- 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.
- 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.
Requirements
- 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.
Benefits
- U.S. based employees may be eligible for short-term and/or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Regulatory Information ManagementRegulatory OperationsVeeva Vault RIMSubmissionsRegistrationsEDMSContent PlanningTechnical WritingBusiness AnalysisProcess Mapping
Soft skills
CommunicationFacilitationStakeholder ManagementInfluencingCollaborationChange ManagementDocumentationTraining DeliveryRequirements GatheringWorkflow Optimization
