Contracts and Grants Manager
Johnson & Johnson Family of Companies is currently recruiting for a Contracts & Grants Manager in Raritan, NJ, Spring House, PA, Titusville, NJ, or Malvern, PA.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $74.3 billion in 2014 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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 C&G function. Assist management in the efficient execution of the contracts and grants processes and in meeting strategic objectives.
Serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/procurement/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 indicators.
Lead recruiting, training, managing, coaching/mentoring, workload prioritizing, and evaluating staff members. Contribute to ensuring optimum utilization of resources and compliance with project deadlines. Execute strong supplier relationship management with flex providers and institutions and drive empowerment.
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.
Continuously work to refine GCDO contracts and grants processes in alignment with stakeholder needs and in compliance with corporate process, systems, and strategies by identifying innovative process improvements, determining feasibility, and collaborating with appropriate parties to implement when appropriate.
Work proactively to increase global awareness of group processes and procedures and train and educate stakeholders.
Assume primary responsibility for tracking, maintenance and accuracy of metrics, contract documents, and supporting documentation.
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.
Assure that contract and budget provisions are in compliance with corporate process, systems, and strategies.
Liaise with the global C&G 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.
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.
Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by CDO management as well as operating companies, corporate, HCC and QA guidelines.
Comply with requests from QA and auditors.
This is not an exhaustive, comprehensive listing of job functions and tasks. Other duties may be performed as assigned.
• Bachelor's degree or equivalent in appropriate scientific or business disciplines.
• 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. 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
• Master’s Degree and/or MBA degree
• Previous work in international and virtual environments desirable
• Previous people management experience preferred
• Knowledge of databases and/or project management systems
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern
Janssen Research & Development, LLC. (6084)