[Innovative Medicine] Lead Regional Contract Manager, Contracting Resource Center

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Position Summary:
Support in the creation and maintenance of Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines.

Support in the development of training related to Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines as required.

Lead/support on the review and negotiation of customized and complex templates.

Expedite contract negotiation and execution by acting as resource for first line negotiators to streamline requests to law department and avoid duplication of efforts among negotiators.

Act as a point of contact with legal department to resolve complex legal issues while ensuring compliance with company process and strategy and subsequently disseminating information to negotiators.
Principal Responsibilities:
• Support creation and maintenance of contract templates in accordance with changes in laws, regulations, or corporate policies
• 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...