Temp-Associate Manager, Site Contracts

Location
Tarrytown, NY, United States
Posted
Sep 16, 2019
Ref
17225BR
Required Education
Bachelors Degree
Position Type
Contract
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.

Summary:

For assigned studies: responsible for (1) managing the CROs who develop and negotiate global investigator site contracts, (2) reviewing CROs' and/or sites' proposed changes to standard contract terms and the study-specific budget parameters (in partnership with other business lines internally), (3) ensuring the delivery of high quality, compliant, effective, and timely site contracts, (4) maintaining productive relationships with internal client groups, and (5) working on ongoing process improvements and guidance documents.

Responsibilities:

• Provide subject matter expertise for assigned therapeutic areas

• Accountable for ensuring that performance and efficiency standards are met for assigned studies

• Perform in a manger that is consistent with Regeneron's values

• Assist with updating Regeneron's site contracting processes

• Engage with the study teams from early planning throughout the end-to-end contracting lifecycle

• Work closely with internal client groups, internal stakeholders, and CROs and effectively communicate with them, in order to ensure that business objectives are met (e.g., scheduled site initiation visit deadlines)

• Handle site contracting related escalations from the CROs and/or the investigator sites, effectively and efficiently

• Develop and enhance relationships with internal clients, internal stakeholders, CROs, and sites

• Partner with colleagues in the Law Department and other stakeholder groups, as needed, to continuously enhance Regeneron's CTAs

• Ensure that internal systems are updated in a timely, accurate, and complete manner

• Ensure that CROs and staff are enhancing site relationships and conducting issue resolution of moderate to high complexity

• Meet with study teams regularly and prioritize assignments

• Stay abreast of changes in industry standards and help identify new best practices to contribute to continuous improvement

• Help train others on site contracting processes and industry practices

• Manage changes to study scope, ensuring timely contract amendment and implementation

• Responsible for making timely decisions and direction of outcomes

• Address changes to study scope to ensure timely contract amendment and implementation

• As a member of cross-functional study teams, lead appropriate agenda topics of the team meeting and provide guidance to line functions

• Single point of contact for internal clients, CROs, and sites for assigned studies

• May require up to 25% Travel
Requirements:

Required minimum of 3 years of direct experience with clinical site contracting at a biopharmaceutical company, CRO, or site

• Ability to mitigate and drive solutions regarding CRO and investigator site contracting challenges

• Ability to identify and implement best practices and contribute to continuous improvement for site contracting

• Ability to influence vendors and internal stakeholders

• Strong knowledge of site contracting practices

• Comfortable participating on and occasionally leading cross functional teams of peers (internal/external customers)

• Functional subject matter expert

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.