Principal RIM Consultant – Regulatory Information Management
Red Nucleus
Vault
Principal RIM Consultant, Regulatory Information Management
Red Nucleus
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Vault
About the role
- Work with Scientific Services & Advisory team
- Work under the direction of a more experienced consultant to help organizations solve issues, create value, maximize growth, and improve business performance
- Work alongside seasoned consultants, subject matter experts, and industry specialists to ensure that all client deliverables meet customer expectations
- Actively contribute to all engagements with varying roles per project
- Represent Red Nucleus in addressing the client’s business requirements and needs
- Project planning and management (PMO)
- Business requirements (research, interviews, workshops)
- Process optimization
- Training (development and deployment of varying formats such as e-learning and instructor-Led)
- Business plan/case
- Strategic plan and roadmap development
- Solution design and implementation
- Innovative system design
- Quality and compliance
- Change management
- User requirements specifications
- User acceptance testing
- Systems validation and implementations
- Document migration
- Helpdesk
- Metrics and KPIs
- Data Governance
- IT/Business liaison
- Contribution to marketing, thought leadership and other initiatives that help drive the success of the SS&A Business unit or Red Nucleus as a whole
Requirements
- 3–5+ years of experience in regulatory operations, regulatory affairs, or data management in the life sciences industry
- Proficiency with regulatory submission processes and Health Authority regulations
- Proven experience with RIMS platforms, including Veeva Vault
- Knowledge of global data standards such as IDMP, xEVMPD, or SPOR is a plus
- Understanding of the pharmaceutical industry, drug development and supporting documents
- Interest in the life sciences industry (both business process and software development)
- Excellent communication skills
- High attention to detail
- Self-starter and driven
- Ability to multi-task with superior organization skills
- Dependable and flexible
- Excellent organizational and communication skills essential to working with global and interdisciplinary teams
- Proficient in Microsoft Suite software including Project, Excel, Word, PowerPoint, Visio
- Bachelor’s degree (minimum requirement)
- Location flexible
- Up to 50% travel may be required
