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Years of Experience
Date Last Verified
Lead, Contract Specialist The candidate will support creation and maintenance of contract templates in accordance with changes in laws, regulations, or corporate policies. Will support creation and maintenance of fallback language and negotiation guidelines related to contract templates. Support training on contract templates and fallback language and provide training to first line negotiators and others as required. Provide specialized support and guidance on the negotiation of CTAs and CDAs to first line negotiators. Work with the legal department to create risk assessments to support the decision-making process. Access risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. Provide guidance to 1st line negotiators, stakeholders and others as required. Lead negotiations on Master Agreements and custom templates or those requiring extensive modifications and identify potential risks to the business. Lead contract negotiations on terms and conditions of high-risk and complex agreements and other relevant legal documents as they relate to clinical trials and company/departmental policies. Coordinate with cross-functional departments to ensure consistency and compliance with process, external communications and policies. Assist in coaching/mentoring staff members. Liaise with all members of clinical team as needed in addition to representatives of investigator sites, academic research organizations, contract research organization, and site management organizations as directed. Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as R&D companies, corporate, HCC and QA guidelines. Collaborate with internal stakeholders to ensure proper dissemination and management of knowledge. Monitor departmental processes to ensure compliance with corporate policies.
Qualification and Experience
The candidate should have a J.D. degree, LL.M. degree, paralegal degree or local equivalent. Must have 5+ years of experience with Contract Law in the Pharmaceutical or Clinical Research industry or equivalent competencies. Demonstrated ability to conduct contract negotiation, legal research and analysis is required. Must have a working knowledge of the clinical development process. Strong relationship management skills are needed. Experience working across different geographic regions in a large global environment is essential.
Requisition ID: 6865180712
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