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IT:
Business Analyst – Veeva Systems

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:

Intellia Therapeutics, Inc. is seeking a Business Analyst – Veeva Systems based at our Cambridge, MA site. You will be responsible for the implementation, validation, and support of our Veeva based applications. This role requires experience in performing the System Administration responsibilities for the Veeva system. Knowledge and experience with Veeva Quality (QDocs, QMS, LMS), Regulatory (RIM) is preferred. Deep understanding of the quality and regulatory submissions processes is a plus. Other key responsibilities include:

  • Provide application administration support, documentation, training, and troubleshooting of Veeva systems that includes quality, clinical, regulatory systems which includes Veeva Quality (QDocs, QMS, LMS), Regulatory(RIM), Clinical (eTMF)

  • Communicate issues, technical failures, and projects status updates

  • Review and implement change controls

  • Perform project management activities in support of business process improvements

Veeva Systems Administration duties include:

  • Management of system access and permissions

  • Perform change management activities in support of system enhancements and user requirements

  • Design solutions and manage configuration

  • Configure and manage integrations to Vault platform

  • Participate in the development of solutions and manage project/change timelines

  • Troubleshoot user issues

  • Author validation deliverables

  • Author Standard Operating Procedures and Work Instructions

  • Provide user trainings

  • Provide technical solutions to requirements that encompass best practice, efficiency, and global considerations 

 

About You: 

Our ideal candidate will have a comprehensive understanding of the Software Development Life Cycle, GAMP 5, and regulatory agency requirements. Your soft skills should include a demonstrated ability to work both independently and as part of a team, and to complete assignments within defined time constraints. Additional role requirements include:  

  • Strong ability to comprehend complex problems and apply knowledge to propose potential solutions

  • Analytical skills to be able to understand the needs of customers and work out priorities

  • Strong written and oral communication skills as well as organizational skills

  • Demonstrated ability to work effectively under established guidelines and instructions

  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment

Experience working the following:  

  • GxP regulated environment, preferably in the biopharma space 

  • Users from the quality, clinical, and regulatory domain

  • Computer systems validation, systems analysis, and support of GxP systems

  • Veeva Systems and SaaS applications

  • Domain knowledge of Quality, Clinical, and Regulatory processes

 

Meet your Future Team:

This role will report directly to the Associate Director, R&D Systems, Information Technology. The R&D Systems’ team is made up of two other individuals, who bring a range of experience and knowledge. While a small team, you will join a group of passionate individuals who enjoy working with one another. Within the R&D Systems group, our stakeholders will include business functions from Research, TechOps, Quality, and Clinical.

While the IT team is currently working virtually, we are tentatively planning a return to the office in September. Although in a virtual environment, the group has made it a priority to continue to foster a sense of community. This includes virtual happy hours, team all-hands meetings, game nights, and more! You can expect to join a hardworking, collaborative environment.

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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.

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.
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