Temp - Manager - COA Licensing Specialist

Tarrytown, NY, United States
Jun 05, 2019
Required Education
Bachelors Degree
Position Type
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 Licensing Specialist is responsible for coordinating the process of obtaining copyright holder permissions for use of Clinical Outcome Assessments (COA). Possessing effective communication skills and strong organizational abilities, the Licensing Specialist will work collaboratively with other business units (e.g. Procurement, Legal, Finance, COA) to ensure timely completion of all licensing processes in line with broader clinical study milestones and deliverables. Additionally, the Licensing Specialist will ensure compliance with all appropriate terms and conditions as contracted with COA developers. The role will also lead the development and maintenance of a robust COA library and Developer database.

Job Duties:

• Responsible for the acquisition of license agreements for clinical outcomes assessments across one or more clinical programs/studies

• Communicates with internal and external stakeholders and escalates risks

• Participates in creation and enforcement of eCOA standards

• Manage licensing and COA requests

• Research COAs to determine appropriate copyright holder and establish licensing requirements

• Coordinate efforts across the organization to secure necessary permissions and license agreements:

• Legal

• Procurement

• Health Economics & Outcomes Research

• Finance

• Clinical Outcomes Assessments & Innovation

• Manage communication related to licensing agreement status and serve as central point of contact for internal and external stakeholders for licensing agreements in clinical trials

• Establish partnerships with COA developers and facilitate the process of drafting Master Service Agreements, where appropriate

• Review invoices for pass through costs in coordination with Clinical Study Lead; and ensure payment of appropriate license fees is completed

• Receive and catalog source documents (English and translations) as received from the license holders and translation vendors

• Maintain and manage COA library

• Track and maintain database of license holders, ensuring compliance with terms and conditions of relevant contracts. Provide support for problem resolution between licensing holder and Regeneron study team

• Monitor financial components related to license agreements for each study


• Demonstrate knowledge of COA systems development processes

• Demonstrated interpersonal & leadership skills

• Demonstrated knowledge of copyright law and licensing/permission requirements for COAs

• Experience in project management and working in a cross functional organization

• Effective verbal and written communication skills

• Ability to see the big picture as well as work hands-on

• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

• Ability to proactively recognize project challenges and implement effective action plans

• Strong organizational skills

• Ability to support and build collaborative relationships both internally and externally

• Demonstrated ability to work independently

Key Team Membership (including, but not limited to):

• COA Manager

Cross Functional Interfaces (including, but not limited to):

• Clinical Study Lead

• Legal

• Health Economics & Outcomes Research

• Procurement

• Clinical Finance

Bachelor's degree and minimum of 3 years relevant industry experience

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.