Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
As the Regulatory Operations Manager joining our growing Regulatory team, you will be instrumental in the adoption and maintenance of the RIM System and contributing to Intellia’s Regulatory Operations capabilities. You will ensure continuous optimization, maximum utilization, and uninterrupted administration of the RIM System to support Regulatory activities including IND/CTA submissions and Health Authority Interactions (HAI). The principal role you will fulfill will be:
Business Administrator for Veeva Vault RIM:
- Anticipate and advocate for system enhancements and functionalities, and work with RIM team to map requirements to RIM program roadmap
- Collaborate closely with IT and QA Validation to complete impact assessments, support development and implementation of solutions including UAT, and manage user groups
- Implement strategy for maximum reuse of cross-program documents and management of docs/binders
- Manage the creation/maintenance of core and related objects, document/binder templates, and Commitments and HAQ database
- Maintain proficiency in Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM
- Contribute to the writing, review, and implementation of standards and procedures related to RIM
- Interact with other System/Business Administrations and Owners across Intellia to improve processes and align where necessary
Primary Contact for RIM Users:
- Provide technical expertise and guidance to users to ensure process adherence including support for workflows, Submission Content Plans, etc.
- Actively solicit and gather feedback to understand evolving business requirements
- Translates feedback/requirements to workable RIM solutions including development of reports/dashboards, document/binder templates, and business requested system/process enhancements
- Implement training strategies, develop training materials, and delivery training for effective adoption of RIM
If you are looking to immediately become a key contributor on a team where your combination of Regulatory submission knowledge and system expertise drives the maintenance and enhancement of a first-in-class RIM system, this is opportunity is for you! We are looking for a detail-oriented candidate who takes pride in delivering quality work, defining and adhering to processes, and providing support to end users. The candidate should have a strong understanding of RIM Systems, eCTD, Regulatory submission/document lifecycles. and have Bachelors degree with 4-8 years of combined Regulatory Operations and/or RIM experience (CMC submissions and Veeva Vault RIM experience preferred).
Meet your future team:
The Regulatory team is growing quickly! We have expanded from 3 people to a team of 11 over the last year. This is an exciting time to join us, as we are starting to build out a regulatory infrastructure that will be needed to support our ambitious regulatory and clinical goals for our investigational products. The team is small, friendly and genuinely enjoy working with each other. We are a passionate group of individuals on a mission to pioneer the approval of CRISPR therapies.
The team is currently working off-site during the COVID pandemic. As the situation improves there are plans to meet once or twice a month as a regulatory group with the flexibility to be on site as much as you prefer. If you join our team, you can expect to join a hardworking and collaborative environment. We look forward to fostering your skills, learning from your experiences, and building a larger team that will make a difference in patients' lives.
Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. Requests for exemption for medical or sincerely held religious beliefs will be considered.
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.