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