Department: Admin/Operations

Specialist, Contracts

Summary:

The Specialist, Contracts is responsible for coordination of the contracting process for internal departments and external parties to develop and execute mutually acceptable agreements, primarily for the procurement of external professional services in an international pharmaceutical development organization.

Coordinates other operational processes/procedures and projects as assigned.

Position description:

  • Initiates and coordinates a wide range of activities within existing standard contracting procedures and personally manages smooth execution of 200+ agreements annually, primarily for securing research and development services from clinical research organizations, clinical trial sites, laboratories, universities, professional services firms.  Identifies and resolves potential issues as needed, and facilitates finalization of agreement.
  • Drafts select types of agreements using standardized templates, such as consulting and confidentiality agreements, and manages them to completion.  Receives final drafts of other types of agreements such as services agreements, strategic collaborations, and material transfer agreements, from originating party and manages them to completion.  Manages workflow internally and externally to secure approvals and final execution of agreements. 
  • Serves as the primary interface for establishment of contracts, working directly with initiating department and contract owner, and interacting with other departments including business development and finance.  Serves as liaison with external legal counsel, as needed.
  • Serves as a primary interface externally with third party for execution of agreement, negotiating terms within established procedures and raising other issues for resolution as needed to ensure all aspects of the agreement are completed satisfactorily.
  • Maintains accurate and detailed records in contracts database while following contracts department’s standard process and procedures for consistent record keeping. Create contracting reports from database for a variety of business needs upon request. Participate in periodic database cleanup and modifications for improved database management.
  • Participates in special projects as needed, such as participating with the Senior Manager, Contracts & Operations in the development, implementation and daily use/adherence to internal contracting processes and procedure, updating and maintaining contract template library, provide training to staff for use of contracts database and digital signature products, and other duties as requested to support a smooth contracting process for the organization.
  • Responsible for compliance with applicable GxP regulations in performing the functions of the job and completion of applicable regulatory trainings provided by the TB Alliance.

Ideal candidates will have:

Three or more years business experience in contracts administration in a clinical research & development setting, ideally in pharmaceutical, clinical research organizations, or other life sciences discipline)

BS/BA in business or other relevant discipline.

Working knowledge of a broad range of contracts including master service agreements, manufacturing agreements, work orders, change orders, clinical trial site agreements, lab agreements, material transfer agreements, research collaboration agreements, consulting agreements, and confidentiality agreements.

Strong detail orientation, analytical and editorial skills, and ability to manage a large number of agreements simultaneously and autonomously.

Strong written and verbal communications and negotiation skills.   

Savvy with learning and implementing new technology, especially database management and use of digital signature products, ideally with a working knowledge of CFR 21 Part 11 compliance (as it relates to clinical contracts).

Highly proficient in all MS Office products and Adobe Acrobat software.

Location:

New York, NY

Organizational Information:

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster, affordable tuberculosis drugs that are available to those who need them.Through innovative science and with partners around the globe, we lead a global effort to ensure development of and equitable access to faster, better tuberculosis cures that will advance global health and prosperity.

With an annual operating budget of approximately $60 million, the TB Alliance leads the advancement of the most comprehensive R&D portfolio of TB drug candidates in history. Additionally, the TB Alliance drives efforts to ensure regulatory approval, country adoption of new regimens, and widespread availability of new drug regimens to patients. For more information, please access the website: www.tballiance.org.

Our Pipeline

TB Alliance manages the largest pipeline of new TB drugs in history.

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