Johnson and Johnson

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 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
• Exemplary customer focus with vision to drive solutions

This is not an exhaustive, comprehensive listing of job functions and tasks. Other duties may be performed as assigned.

Principal Relationships:

This position reports to Manager Contract Specialist.

Internal:

• Internal Business Partners (CCS, TA, MAF, MAO, GCDO, JRP, HCC, Risk Management, Legal, etc.)

External:

• Clinical Investigator Sites
• Commercial Suppliers
• Clinical Research Organizations (when applicable)

Education and Experience Requirements:

• Bachelor’s degree or Equivalent in appropriate scientific or business disciplines (Preferred MBA or Equivalent Other Juris Doctor (JD), Master of Laws (LLM), or local equivalent).
• At least 5 years’ experience with contract law in the pharmaceutical/clinical research industry and/or equivalent competencies in relevant fields with demonstrated ability to conduct contract negotiation, legal research and analysis
• Must have a working knowledge of the clinical development process
• Excellent oral and written communication skills and sensitivity to cross-cultural communication
• Strong relationship management skills and experience
• Ability to work effectively across all levels of management
• Strong and proven issue identification and problem resolution skills
• Sense of urgency with ability to manage competing priorities while meeting deadlines
• Working knowledge of PCs, MS Office and database management
• Business acumen and complex project management skills
• Must demonstrate strong interpersonal and leadership skills with a strong drive to mentor and coach team members

DECISION-MAKING AND PROBLEM-SOLVING

• Adhere to SOPs, ethics and departmental compliance as determined by JRP management as well as business partners, operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with JRP, GCDO and operating companies. Comply with requests from QA and auditors.
• Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.
• Able to work independently as well as in a collaborative team environment.

Other:

• Language Requirement: Fluency in English
• Travel Percentage: 10% (Domestic & International)

＜ For Internal Applicants ＞

• If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
• Once you move to 1st interview stage, please make sure to inform to your current manager.
• For Employee Referral Program (ERP), please read and understand the details of “Employee Referral Program” in Ask GS and make a compliant referral.
• Based on your experience and interview evaluation, the position title and level may vary.