Vacancy expired!
Lead, Regional Contract Manager, Contracting Resource Center - 2306113757WDescriptionJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Lead Regional Contract Manager, Contracting Resource Center to be remote based in the United States.At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.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.Key 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 standard processes. 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
Outstanding customer focus with vision to drive solutions
Principal Relationships:This position reports to Manager Contract Resource Center.Internal:
Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.)
External:
Clinical Investigator Sites
Commercial Suppliers
Clinical Research Organizations (when applicable)
QualificationsEducation:
Bachelor’s degree or Equivalent in appropriate scientific or business fields (Preferred MBA or Equivalent Other Juris Doctor (JD), Master of Laws (LLM), or local equivalent).
Experience and Skills:Required:
Minimum of 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 solid understanding of the clinical development process
Excellent oral and written communication skills and sensitivity to cross-cultural communication
Strong relationship leadership 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 balance multiple priorities while meeting deadlines
Working knowledge of PCs, MS Office and database management
Business sense and sophisticated 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 GD 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.
The base pay range for this position is $102,000 to $163,300.The anticipated base pay range for this position in the San Francisco Bay Area, CA is $116,700 to $187,795.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefitsAt Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.Primary Location NA-US-New Jersey-TitusvilleOther Locations NA-United StatesOrganization Janssen Research & Development, LLC (6084)Job Function Clinical Trial AdministrationReq ID: 2306113757W
Vacancy expired!