Manager, Medical Affairs Site Contracts

Location
Tarrytown, NY, United States
Posted
Aug 23, 2019
Ref
17222BR
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.

Summary:
Responsible for (1) developing and negotiating global investigator-initiated study ("IIS"), compassionate use, and Regeneron sponsored Phase IV non-interventional studies (i.e., patient registries) budgets and contracts, (2) reviewing 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 sites, and (5) contributing to ongoing process improvements.

Responsibilities:
  • Act as the single point of accountability for assigned studies.
  • Draft and negotiate a range of clinical contracts within guidelines provided by the Law Department, on a wide variety of matters
  • Proactively follow up with internal and external stakeholders from the time the contracting request is received through resolution/execution to ensure shortest cycle times
  • Prioritize and follow through on a high volume of client requests
  • Resolve client requests in a professional and timely manner, escalating as necessary
  • Understand and comply with all relevant procedures and policies
  • Assist in maintaining the contracts database and alert clients to key contract dates (e.g., renewal, expiration, etc.)
  • Ability to work independently and manage agreements from initiation to completion with little or no supervision
  • Ability to train team members on contracts group policies and procedures
  • Proven capability to influence people
  • Provide subject matter expertise
  • Accountable for ensuring that performance and efficiency standards are met
  • Perform in a manner that is consistent with Regeneron's values
  • Assist with developing and updating Regeneron's IIS and Phase IV non-interventional study budgeting and contracting processes
  • Engage with Medical Affairs teams from early planning throughout the end-to-end contracting lifecycle
  • Work closely with internal client groups, internal and external stakeholders, and sites and effectively communicate with them, to ensure that business objectives are met
  • Handle site contracting related escalations effectively and efficiently
  • Develop and enhance relationships with internal clients, internal and external stakeholders, and sites
  • Partner with colleagues in the Law Department and other stakeholder groups, as needed, to continuously enhance Regeneron's contract templates and tools
  • Ensure that internal systems are updated in a timely, accurate, and complete manner
  • Enhance site relationships and conducting issue resolution of moderate to high complexity
  • Meet with Medical Affairs 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 internal 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
  • Contribute to ongoing, process improvements
  • Help onboard and train new staff

Requirements
  • Required minimum of 3 years of direct experience with clinical trial agreements, ideally with IIS type studies, compassionate use agreements, and Phase IV non-interventional studies at a biopharmaceutical company, CRO, or site
  • Bachelor's Degree (required); Master's Degree or Juris Doctor (Preferred)
  • Ability to mitigate and drive solutions regarding Medical Affairs contracting challenges
  • Ability to identify and implement best practices and contribute to continuous improvement
  • Ability to influence vendors, sites, and internal stakeholders
  • Strong knowledge of IIS, compassionate use, and Phase IV non-interventional study contracting practices
  • Comfortable participating on and occasionally leading cross functional teams of peers (internal/external customers)
  • Ability to effectively onboard, train, and mentor peers
  • Ability to lead ongoing, process improvements (including participating on strategic initiatives)
  • Functional subject matter expert

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.