Role Summary
Principal Capability Professional for Registration Tracking xEVMPD. Morristown, NJ / Cambridge, MA.
Responsibilities
- Define and drive cross-domain capability roadmaps with enterprise impact.
- Contribute to enterprise-level process architecture and governance, balancing standardization and innovation.
- Design and orchestrate complex workshop programs and testing strategies to support solution development and validation.
- Develop enterprise compliance strategies and risk mitigation approaches.
- Represent the organization during critical audits and regulatory inspections related to Registration Tracking and Data Information Flow Capability.
- Drive transformational process improvements with significant ROI across end-to-end regulatory capabilities.
- Serve as Business System Owner (BSO) for Veeva RIM, overseeing governance, documentation, and strategic alignment.
- Manage Registration Tracking backlog in JIRA and triage against Back to Standard Program.
- Lead resolution of Level 3 support issues and complex modeling challenges.
- Evaluate and champion strategic technology investments in regulatory capability development, digital adoption, and AI.
- Analyze Veeva releases and roadmap critical features for future adoption.
- Contribute to structured data submission readiness (gradual IDMP implementation in multiple regions, such as PMS enrichment for Europe).
- Design enterprise change management frameworks and governance with Training and Communication teams.
- Facilitate Functional Lead forums and present best practices to Super Users.
- Develop talent and lead workstreams across Regulatory, Digital, and Data Governance.
- Focus on the end-to-end flow of regulatory registration tracking data across various stages, departments, and systems as BSO for Vault RIM RT.
- Collaborate with Process Owner (GRO) and Product Owner (Digital) for Registration Tracking and Data Transactions to ensure alignment between system development and process operationalization.
Qualifications
- Required: 10+ years of leadership in regulatory operations.
- Preferred: Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent.
Skills
- Expert knowledge of Veeva Vault RIM Registration Tracking, IDMP standards, and structured data submissions.
- Proven ability to optimize regulatory business processes.
- Expert understanding of capability-based planning, agile delivery, and digital product lifecycles.
- Strategic vision for digital tools, automation, and AI implementation.
- Strong communication and collaboration skills in a matrixed organization; ability to lead and drive change in a cross-functional environment.
Education
- BS/BA required.
- Master's degree or specialized training preferred.