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:
People Leader
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
POSITION SUMMARY:
Principal accountability is to ensure that contract and grants processes function effectively and efficiently for assigned personnel/function with a focus on the successful progression and management of the assigned CCS function. Assist management in the efficient execution of the contracts and grants processes and in meeting strategic objectives.
PRINCIPAL RESPONSIBILITIES:
- Serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/CCS/GCDO policies and procedures as they relate contracts and grants functions.
- Lead business partner communications and strategy intelligence for all trials and leadership team reporting of metrics and key performance
- Work closely with global stakeholders: establish and maintain working relationships with J& J business partners, health care compliance, risk
- management, J& J legal, insurance broker(s), privacy, suppliers, customers and other identified stakeholders.
- Act as subject matter expert of regional requirements, practices and regulations as they relate to clinical contracts and grants. Contribute to building a knowledge management system of global requirements for contracts and grants functions.
- Responsible for analyzing contract requests/needs from operating companies and proactively translating into appropriate clinical contracts/budgets. Lead negotiation and execution of agreements including specialized support for negotiations in confidentiality agreements, informed consent forms, amendments and other ancillary contract documents as required.
- Analyze investigator grants for fair market value aligned with regional knowledge, compliance guidance and the J& J grant pricing guidelines.
- Lead the approval escalation of grants as appropriate Manage CROs contracted to negotiate CTAs globally, inclusive of training and supervision.
- Responsible for assessing risks of budget and legal provisions independently. Provide solution and business focused advice to stakeholders and others within J& J on contract and grant related topics
- Establish master agreements, lean process enhancements and other innovative solutions to expedite site initiation
- Review, authorize and/or manage payments where appropriate. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
- This is not an exhaustive, comprehensive listing of job functions and tasks. Other duties may be performed as assigned.
- Travel: Minimum travel required. ·The ability to travel up to 30% of the time
DECISION-MAKING AND PROBLEM-SOLVING:
- Assure that contract and budget provisions are in compliance with corporate process, systems, and strategies. Liaise with the global CCS team, J& J Corporate Law, Local Legal Counsel, CDO Colleagues, Healthcare Compliance, Risk Management, Privacy and other stakeholders to escalate and resolve issues as appropriate.
COMPETENCIES:
CONNECT Develop deep insights into the needs of our patients, customers, markets and communities.
- Cultivate external relationships and partnerships.
- Be insight-driven to uncover unmet needs
- Forge internal collaboration across all levels of the enterprise.
SHAPE Drive innovation; anticipate and shape industry and market changes to advance health care globally.
- Translate insights into viable products and solutions that create value
- Challenge the status-quo; lead and adapt to change
LEAD Create an environment where leadership and talent development is top priority.
- Take ownership for talent acquisition, performance and development of self and others
- Maximize the power of diversity and inclusion
- Engage in transparent and constructive conversations
DELIVER Drive results by inspiring and mobilizing people and teams.
- Empower people to act with speed, agility, and accountability.
- Demonstrate a global and enterprise-wide mindset
- Balance short and long-term strategic choices
LIVE OUR CREDO Demonstrate and inspire the behaviors that reinforce Our Credo.
- Serve as a role model for making Credo-based decisions.
- Create a trusting, collaborative, and ethical work environment.
- Maintain the highest standards of quality, compliance and accountability.
- Champion programs and initiatives that support our environment and communities
REPORTING RELATIONSHIPS:
This role reports to the Contracts and Compliance Service site engagement director APAC.
WORKING RELATIONSHIPS/INTERFACES:
Will interface with internal Business Partners (CCS, TA, MAF, MAO, GCDO, JRP, HCC, Risk Management, Legal, etc.) outside parties such as Clinical Investigator Sites, Commercial Suppliers and Clinical Research Organizations (when applicable).
EDUCATION & EXPERIENCE REQUIREMENTS:
- Bachelor's degree or equivalent in appropriate scientific or business disciplines, master’s degree and/or MBA preferred
- At least 6 years of experience in clinical trial operations. At least 3 years’ experience in clinical trial investigator contracting, budgeting and negotiation.
- Understanding of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
- Fluency in English required
- Experience in project management and/or logistics is mandatory
- Working knowledge of MS Office suite at a minimum, knowledge of databases and/or project management systems is a plus
- Must demonstrate innovative spirit, strong interpersonal and leadership skills and complex project management
- Must be able to handle high volume of work and meet very aggressive deadlines
- Previous work in international and virtual environments desirable
- Previous people management experience preferred
＜For Internal Applicants＞
- Based on your experience and interview evaluation, the position title and level may vary.
- 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.
- For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.
Please see the job description for required or recommended skills.
Please see the job description for benefits.