Red Nucleus

Principal RIM Consultant – Regulatory Information Management

Red Nucleus

full-time

Posted on:

Origin:  • 🇬🇧 United Kingdom

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Job Level

Lead

Tech Stack

Vault

About the role

  • 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 all client deliverables meet customer expectations
  • 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 (e-learning and instructor-led)
  • Business plan/case development
  • 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 support
  • Metrics and KPIs
  • Data Governance
  • IT/Business liaison
  • Contribute to marketing, thought leadership and other internal initiatives to drive 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
  • Working in a global environment with an understanding of cultural differences and work practices
  • Bachelor’s degree (minimum requirement)
  • Location flexible
  • Up to 50% travel may be required
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