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MANAGER, CONTRACTS & GRANTS-9233140116
Description
Janssen Research & Development LLC, a Johnson & Johnson company, is currently recruiting for a Manager, Contracts & Grants to be located in Titusville, NJ, Raritan, NJ, Malvern, PA or Springhouse, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Manager, Contracts & Grants will 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. S (He) will assist management in the efficient execution of the contracts and grants processes and in meeting strategic objectives.
The Manager, Contracts & Grants will serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/GDO policies and procedures as they relate to contracts and grants functions. The Manager will assist in recruiting, training, managing, coaching/mentoring, workload prioritizing, and evaluating staff members. Contribute to ensuring optimum utilization of resources and compliance with project deadlines. The Manager, Contracts & Grants will work closely with stakeholders that are globally located: establish and maintain working relationships with J&J risk management, J&J legal, insurance broker(s), privacy, vendors, customers and other identified stakeholders. Liaise with the global C&G team, J&J Corporate Law, Local Legal Counsel, GDO Colleagues, Healthcare Compliance, Risk Management, Privacy and other stakeholders to escalate and resolve issues as appropriate.
The Manager, Contracts & Grants will continuously work to refine GDO 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. The Manager will work proactively to increase global awareness of group processes and procedures and train and educate stakeholders. The Manager will assume responsibility for ongoing tracking, maintenance and accuracy of metrics, contract documents, and supporting documentation to ensure inspection readiness and compliance with departmental and J&J policies, procedures and work instructions. 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.
The Manager, Contracts & Grants will be responsible for analyzing contract requests/needs from operating companies and 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.
The Manager, Contracts & Grants will 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, oversight of tracking, escalations and monitoring/reporting of any gaps or support needed to ensure timelines and expectations are met. The Manager will be 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. Support establishing master agreements and other innovative solutions to expedite site initiation. Assure that contract and budget provisions are in compliance with corporate process, systems, and strategies. Review, authorize and/or manage payments. 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 GDO management as well as operating companies, corporate, healthcare compliance 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.
Qualifications
A minimum of a Bachelor's degree or equivalent is required in appropriate scientific or business disciplines, Master's degree and/or MBA preferred. A minimum of 6 years of experience in clinical development with a pharmaceutical company or CRO or investigator site is required. Previous experience in investigator site contracting is preferred. Understanding of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) required. Experience in project management and/or logistics is required. Working knowledge of MS Office suite at a minimum, knowledge of databases and/or project management systems is a preferred. 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 preferred. Previous people management experience preferred.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-New Jersey-Titusville
Other Locations:North America-United States-Colorado-Denver, North America-United States-Pennsylvania-Spring House, North America-United States-Colorado-Fort Collins, North America-United States-Pennsylvania-Malvern, North America-United States-Colorado-Boulder
Organization: Janssen Research & Development, LLC. (6084)
Job: Clinical Trial Coordination
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
MANAGER, CONTRACTS & GRANTS-9233140116
Description
Janssen Research & Development LLC, a Johnson & Johnson company, is currently recruiting for a Manager, Contracts & Grants to be located in Titusville, NJ, Raritan, NJ, Malvern, PA or Springhouse, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Manager, Contracts & Grants will 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. S (He) will assist management in the efficient execution of the contracts and grants processes and in meeting strategic objectives.
The Manager, Contracts & Grants will serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/GDO policies and procedures as they relate to contracts and grants functions. The Manager will assist in recruiting, training, managing, coaching/mentoring, workload prioritizing, and evaluating staff members. Contribute to ensuring optimum utilization of resources and compliance with project deadlines. The Manager, Contracts & Grants will work closely with stakeholders that are globally located: establish and maintain working relationships with J&J risk management, J&J legal, insurance broker(s), privacy, vendors, customers and other identified stakeholders. Liaise with the global C&G team, J&J Corporate Law, Local Legal Counsel, GDO Colleagues, Healthcare Compliance, Risk Management, Privacy and other stakeholders to escalate and resolve issues as appropriate.
The Manager, Contracts & Grants will continuously work to refine GDO 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. The Manager will work proactively to increase global awareness of group processes and procedures and train and educate stakeholders. The Manager will assume responsibility for ongoing tracking, maintenance and accuracy of metrics, contract documents, and supporting documentation to ensure inspection readiness and compliance with departmental and J&J policies, procedures and work instructions. 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.
The Manager, Contracts & Grants will be responsible for analyzing contract requests/needs from operating companies and 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.
The Manager, Contracts & Grants will 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, oversight of tracking, escalations and monitoring/reporting of any gaps or support needed to ensure timelines and expectations are met. The Manager will be 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. Support establishing master agreements and other innovative solutions to expedite site initiation. Assure that contract and budget provisions are in compliance with corporate process, systems, and strategies. Review, authorize and/or manage payments. 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 GDO management as well as operating companies, corporate, healthcare compliance 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.
Qualifications
A minimum of a Bachelor's degree or equivalent is required in appropriate scientific or business disciplines, Master's degree and/or MBA preferred. A minimum of 6 years of experience in clinical development with a pharmaceutical company or CRO or investigator site is required. Previous experience in investigator site contracting is preferred. Understanding of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) required. Experience in project management and/or logistics is required. Working knowledge of MS Office suite at a minimum, knowledge of databases and/or project management systems is a preferred. 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 preferred. Previous people management experience preferred.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-New Jersey-Titusville
Other Locations:North America-United States-Colorado-Denver, North America-United States-Pennsylvania-Spring House, North America-United States-Colorado-Fort Collins, North America-United States-Pennsylvania-Malvern, North America-United States-Colorado-Boulder
Organization: Janssen Research & Development, LLC. (6084)
Job: Clinical Trial Coordination
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.