Salary
💰 $80,000 - $200,000 per year
About the role
- Lead MedTech customers through regulatory transformation via implementation of Veeva RIM applications
- Partner with customer SMEs and business leaders to analyze, develop, and implement regulatory processes (Submissions, Submissions Archive, Registrations, Publishing)
- Analyze and document current-state business processes, identifying pain points and system or process gaps
- Define roll-out strategies for global deployment of Veeva RIM across regulatory teams
- Serve as primary customer liaison managing communication between project team, customer, and internal stakeholders
- Represent Professional Services across multiple engagements and workstreams (solution design and configuration, data migration, systems integration, etc.)
- Translate customer requirements into solution design and shape future-state vision incorporating global regulatory needs
- Mentor project team and junior consultants in the Professional Services organization
Requirements
- 8+ years of experience implementing regulatory information management systems and processes (e.g., Registration Data Tracking Systems, Submission systems)
- Working knowledge of life sciences compliance, regulatory guidance, and day-in-the-life regulatory business processes
- Ability to quickly understand business use cases and create process and business improvements aligned with Preferred Vault Practices
- Experience implementing software systems and translating business requirements into solution designs
- Proven expertise in customer leadership and mentoring of team members
- Demonstrated stakeholder management, critical thinking, and ability to conduct complex technical communications
- Ability to travel up to 50%
- Nice to have: Direct experience with Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, IQVIA, Trackwise, or other RIM systems
- Nice to have: Consulting experience with a major software vendor or process management consulting group
- Nice to have: Regulatory Affairs, Regulatory Operations, or Submissions Management background
- Nice to have: Life Science, computer science, biochemical or mechanical engineering or related degree
- Nice to have: SaaS/Cloud experience