Senior Manager, UAT, IRT Services

Tarrytown, NY
Apr 15, 2019
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.


The UAT Senior Manager, CDRA Systems, is a key member of the Interactive Response Technology (IRT) organization who is responsible for supporting User Acceptance Testing (UAT) efforts of all IRT systems.
The position requires subject matter expertise in validation/testing IRT systems, excellent business analysis, and project management skills. This individual collaborates with several functional areas and personnel in understanding user acceptance challenges, and proposes solutions and provides leadership. He/she must have excellent interpersonal, presentation, and writing skills as the role will require the development of test plans and their execution with clinical operation team members.

Job Duties:

Essential Functions required for the job. List both technical and managerial requirements if applicable.

• Establish and maintain testing methodology against sponsor standards for 3rd party system deliverables.

• Lead UAT efforts by developing and implementing best practices and procedures for complete end user test plans.

• Responsible for overall success of user acceptance testing, including results verification and subsequent release approvals with IRT Managers.

• Understands industry-specific issues faced in sponsor driven IRT UAT efforts and understands regulatory health authority requirements for testing and documentation requirements.

• Will need to gather information about current work processes and information flows, document existing business process to define new enhancements to gain better efficiency in the testing process.

• Has strong knowledge of testing processes, methodologies and tools

• Can communicate effectively via email and conference calls as needed.

• Will need to be able to interpret IRT study specific requirements and its alignment to study protocols to ensure proper risk mitigation while developing test plans.

• Participates in the tracking and management of open issues and raises ongoing issues

• Ensures all user acceptance tests are documented according to standards.

• Responsible for mentoring and training new personnel as needed.


• Bachelor's Degree in IT, Computer Science preferred

• Minimum 6 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years of experience with Quality Assurance, Validation, and/or Testing of IRT Systems.

• Working knowledge of the IRT terminology and computer programming terms.

• Knowledge of ICH/GCP and regulatory guidelines/directives;

• Disease/therapeutic area knowledge (a plus).

• Leadership and negotiation skills; Mentoring/coaching skills.

• Ability to effectively multi-task and prioritize.

• Effective problem solving skills.

• Written and verbal communication and presentation skills in small and large group settings.

• Project management and organizational skills.

• Computer skills, with competency in MS Office Suite.

• Cross functional and cross-cultural awareness.

• Ability to work in a matrix environment.

• Bachelor's Degree in IT, Computer Science preferred

• Minimum 6 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years of experience with Quality Assurance, Validation, and/or Testing of IRT Systems.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.