Lead Regional Contract Manager

Johnson and Johnson is currently seeking a Lead Regional Contract Manager. This position can be located remotely within the United States or Canada.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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.

Primary 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 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 GD 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

• Exemplary customer focus with vision to drive solutions