bluebird bio's Regulatory Science team is focused on the efficient development of our gene therapy products to bring safe and efficacious products to the market to improve, and hopefully transform, patients' lives. We have a lot of work to do across our Severe Genetic Diseases Franchise and our Oncology Franchise. Patients are waiting and we know we are making a difference every day when we show-up to the nest!
As Regulatory Science team member, you will work with (*surprise*) the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to improve Regulatory Science. We see regulators as partners. Our core principles are to be transparent and proactive in our communication with them and to use science-based reasoning. Gene therapy is innovative and so are the regulatory birds! If you're interested in pioneering gene therapy with purpose, come fly with us!
This role will report to the Director of Regulatory Operations and is responsible for Regulatory Technology business analysis (including defining user requirements, identifying emerging business needs, coordinating with IT on implementation requirements) and business system ownership. This person will serve as first point of contact for training and troubleshooting of regulatory technology and escalate to IT technical issues requiring additional support.
* Drive the implementation of Regulatory Information Management systems.
* System administrator for Regulatory Operations systems, including EDMS (Veeva Vault) and eCTD builder (ACUTA ARIM)
* Lead business analysis and implementation support for additional systems, including Regulatory Information Management (RIM)
* Develops robust and sustainable processes to govern system utilization and administration
* Maintain a strong understanding of regulatory business processes and process needs. Identify current capabilities and future needs and develop plans to build & maintain. Prioritize and share with Information Technology Business Partner (ITBP). Effectively ensure alignment between regulatory needs and IT priorities.
* Maintains basic understanding of operating status of regulatory systems and proactively identifies opportunities for improvement.
* Communicates within Regulatory regarding implementation plans and overall schedules for changes to technology platform or components
* Change Management - Performs assessment of new system releases in support of upgrades. Monitor Regulatory business process changes (including regulatory personnel forecasts) that may have an impact on technology.
* Define business requirements in collaboration with colleagues in IT
* Develop and implement effective and sustainable training program to ensure new and current users of the systems understand how to use the system
* A Bachelor's degree or Master's degree, ideally in a software or other computer science related field, is preferred
* Veeva Vault Administration & ACUTA ARIM Training or Certification is ideal
* 4+ years of regulatory experience in a fast-paced, innovative drug development environment
Capabilities and Qualifications:
* Proven ability to successfully plan for and manage simultaneous system implementations while overseeing the routine daily maintenance of existing regulatory applications
* Successfully manage regulatory systems projects such that they integrate effectively with the overall objectives of the development programs they support
* Expert in MS Office software suite, including Word, Excel, PowerPoint, Visio, and Project
* Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
* Outstanding communication (both written and oral) and collaborative skills and a will to understand the complexity related to the development, -implementation, and maintenance of regulatory systems.
* Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
* Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
* Passion for addressing the critical unmet medical needs of patients
* Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
* Entrepreneurial professional looking to lead a new discipline within the established Regulatory Operations function
About Bluebird Bio
Bluebird Bio offers products based on the transformative potential of gene therapy for patients with genetic and orphan diseases.