Expedite contract negotiation and execution by acting as legal resource for the Contracts and Grants group to streamline requests to law department and avoid duplication of efforts among Contract & Grants Analysts. Act as main point of contact with legal department to resolve complex legal issues while ensuring compliance with company process and strategy and subsequently disseminating information to C&G team members.
Act as liaison between Law Department and Contract and Grant Analysts.
Serve as approving authority in conjunction with the law department.
Assist in coaching/mentoring staff members.
Analyze, manage and expedite resolution of complex legal issues in clinical trial contracting process.
Serve as subject matter expert for healthcare compliance issues in clinical trial contracting.
Assist management in implementation of contract execution process.
Act to coordinate intra-departmental functions to ensure consistency and compliance with process, external communications and policies (clinical trial agreements, confidential disclosure agreements, informed consent forms, etc.).
Coordinate and assist in drafting and implementation of intra-company agreements and other relevant legal documents to ensure compliance with corporate process, system and strategies.
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.
Lead/conduct 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.
Responsible for assessing risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. Provide advice to Contract and Grants Analysts, stakeholders and others within J&J on contracts and grants.
Participate in the development of GCO Contracting infrastructure and direction.
Assume responsibility for all aspects of legal document tracking.
Develop and maintain contract templates in accordance with changes in laws, regulations, or corporate policies.
Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GCO management as well as R&D companies, corporate, HCC and QA guidelines.
Collaborate with members of Contracts and Grants to ensure proper dissemination and management of knowledge.
Monitor departmental processes to ensure compliance with corporate policies.
This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
•Juris Doctor (JD) degree required, licensed attorney preferred
•At least 8 years contract law in the pharmaceutical industry and/or equivalent competencies in pharmaceutical industry/clinical research
•Must have a working knowledge of the clinical development process with at least 5 years of negotiation and contract negotiation experience
•Excellent communication skills both written and oral
•Previous industry/academic relationship management experience preferred
•Ability to work effectively across all levels of management
•Strong and proven negotiation and problem resolution skills
•Working knowledge of PCs and database management
Janssen Pharmaceutical K.K. (7195)ジョブ
Clinical Trial AdministrationRequisition ID