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Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
The Sr. Manager, Interactive Response Technologies (IRT) is responsible for the management and oversight of all Medical Organization IRT related systems and capabilities. This position will establish and maintain strong working relationships with IRT service providers, as well as oversee all IRT system planning, setup, deployment, and maintenance activities, including but not limited to generation of system specifications, oversight of system builds, and assurance of adequate system testing/validation prior to go-live. This position will manage IRT support of and integration with Clinical Operations and Clinical Supply vendor systems to ensure adequate, compliant, and transparent delivery of clinical supply to study sites in line with the clinical trial protocol and all applicable ICH GCP and regulatory requirements, and will also support development of system user roles to plan (including all applicable user roles and permissions required by clinical trial sites, Clinical Operations, Clinical Supply, Pharmacovigilance, and Clinical Development). This role will support system integration with sponsor reporting hubs as applicable (e.g., CTMS) and will ensure system reporting functionalities operate to plan (e.g., system generated reports, notifications, etc.). This position will support creation and maintenance of IRT related procedures and documentation (e.g. SOPs, Work Instructions, etc.), will oversee all IRT related updates and change controls, and will serve as the main POC for IRT related issue escalation and resolution. Candidates must have mastered clinical trial execution and must be able to oversee IRT functionality under ICH GCP requirements. Candidate must have the ability to prioritize multiple tasks, communicate effectively, and cultivate strong cross functional relationships.
\nWhat You'll Be Doing
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.
We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!
In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.
Full Time
Durable Manufacturing
$148k-185k (estimate)
05/19/2024
07/18/2024
regenxbio.com
ROCKVILLE, MD
200 - 500
2009
Public
VURGHUN AHMADOV
$500M - $1B
Durable Manufacturing
REGENXBIO research and develops adeno-associated viral gene therapies for treatment of lysosomal storage disorders and ocular diseases.