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Principal RIM Consultant (Regulatory Information Management)

Principal RIM Consultant (Regulatory Information Management)

Red NucleusWashington, DC, US
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Red Nucleus Principal Rim Consultant

Red Nucleus is hiring a Principal level RIM Consultant to join our global team! This is a remote-based role within the US. Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 900 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.

At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves. Our culture is about meaningful work, a true sense of community, and fun. We love to celebrate our people and we are proud to have been Internationally recognized as a "Great Place to Work".

How You Will Contribute

In this position, you will be working with our Scientific Services & Advisory team. As a Principal RIM Consultant at Red Nucleus, you will be working under the direction of a more experienced consultant to help organizations solve issues, create value, maximize growth, and improve business performance. You will be working alongside seasoned consultants, subject matter experts, and industry specialists to ensure that all client deliverables meet customer expectations. The role will require you to represent Red Nucleus in addressing the client's business requirements and needs.

The projects you may be involved in and the tasks you will given to complete will depend on the area you are working on, but general responsibilities include (but are not limited to) :

  • 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

Internal responsibilities may include, but is not limited to, contribution to marketing, thought leadership, and other initiatives that help drive the success of the Scientific Services and Advisory (SS&A) Business unit or Red Nucleus as a whole.

About You

Ideal candidates will meet the following qualifications :

  • 35+ 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).
  • Other :

  • The level of this position will be considered per applicant experience.
  • Location flexible.
  • Up to 50% travel may be required.
  • What You Will Enjoy at Red Nucleus :

  • Competitive pay, incentives, retirement, and income security programs.
  • Comprehensive benefits and wellness programs focused on healthy lifestyles.
  • Generous paid time off, employee assistance programs, and flexible work arrangements.
  • Performance-driven environment including professional development and transfer opportunities.
  • People-first culture fostering self expression, diversity, and a growth mindset.
  • Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones, and anything else that is meaningful to our employees.
  • Support of the community organizations you are passionate about.
  • Ongoing programs and events designed to bring our global team together.
  • Diversity, equity, and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit. We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.

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