Associate Director, Site Engagement at Johnson & Johnson in Spring House, PA
Job Description Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Associate Director, Site Engagement. This position can be located in Spring House PA; Titusville, NJ; or Raritan, NJ. Remote work options within North America may be considered on a case-by-case basis and if approved by the company. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. The Associate Director, Site Engagement will have principal accountability 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 Contract and Centralized Services (CCS) function. This individual will also be accountable for focusing on the support model and strategic development of the direction of contracting with investigative sites. Management of the efficient execution of the contracts and grants processes in meeting strategic objectives. Principal
Responsibilities:
Assist and learning to lead and drive innovation and related activities for investigator site contracting. Serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/Global Development (GD) policies and procedures as they relate to contracts and grants functions. 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. Leverage expertise & efficiencies in clinical site contracting across therapeutic areas, recognize opportunities for enhancements, identify and implement solutions. Work closely with stakeholders that are globally located:
establish and maintain working relationships with Johnson & Johnson risk management, Johnson & Johnson legal, insurance broker(s), privacy, vendors, customers and other identified stakeholders. Liaise with the global CCS team, Johnson & Johnson Corporate Law, Local Legal Counsel, GD Colleagues, Healthcare Compliance, Risk Management, Privacy and other stakeholders to escalate and resolve issues as appropriate. Continuously work to refine Global Clinical Operations (GCO) CCS 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. Identify and execute goals aligned with organizational objectives as defined in the GD and CCS cascades. Assume responsibility for ongoing tracking, maintenance and accuracy of metrics, contract documents, and supporting documentation to ensure inspection readiness and compliance with departmental and Johnson & Johnson 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. Identify and promote best practices. Adhere to Standard Operating Procedures (SOPs), ethics and departmental compliance as determined by GD management as well as operating companies, corporate, Health Care Compliance (HCC) and Quality Assurance (QA) guidelines. Develop employees, as applicable, via HR Planning programs including but not limited to Performance and Development Management (PDM) and training to meet current employment opportunities and endorse the value of a diverse work force; Assist in recruiting, managing, coaching/mentoring, workload prioritizing, and evaluating cross-functional staff members. Analyze 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. Analyze investigator grants for fair market value aligned with regional knowledge, compliance guidance and the Johnson & Johnson grant pricing guidelines. Lead the approval escalation of grants as appropriate. Manage Contract Research Organizations (CROs) contracted to negotiate Clinical Trial Agreements (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. Assess risks of budget and legal provisions independently. Provide solution and business focused advice to stakeholders and others within Johnson & Johnson 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 GD management as well as operating companies, corporate, healthcare compliance and QA guidelines and requests for auditors. Exemplary customer focus with vision to drive solutions. Qualifications A minimum of a Bachelor's degree is required. A minimum of 6 years of contract experience in clinical operations with a Pharmaceutical company, Contract Research Organization (CRO) or investigator site is required. Knowledge of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is required. Knowledge of the clinical development process is required. People management experience is preferred. Experience in project management and/or logistics is preferred. Knowledge of databases and/or project management systems preferred. Previous work experience in international and virtual environments preferred. Must have excellent communication and interpersonal skills. Must have strong negotiation, decision-making and problem-solving skills. Must have the flexibility to manage through ambiguity with minimal direction and motivate team members. The ability to handle a high volume of work and meet very aggressive deadlines is required. The ability to collaborate with all levels in a cross-functional team environment. This position will require 10% travel. The anticipated base pay range for this position is $129,500 to $194,000.
Salary Range:
$100K -- $150K
Minimum Qualification
Operations Management, ProcurementEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Assist and learning to lead and drive innovation and related activities for investigator site contracting. Serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/Global Development (GD) policies and procedures as they relate to contracts and grants functions. 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. Leverage expertise & efficiencies in clinical site contracting across therapeutic areas, recognize opportunities for enhancements, identify and implement solutions. Work closely with stakeholders that are globally located:
establish and maintain working relationships with Johnson & Johnson risk management, Johnson & Johnson legal, insurance broker(s), privacy, vendors, customers and other identified stakeholders. Liaise with the global CCS team, Johnson & Johnson Corporate Law, Local Legal Counsel, GD Colleagues, Healthcare Compliance, Risk Management, Privacy and other stakeholders to escalate and resolve issues as appropriate. Continuously work to refine Global Clinical Operations (GCO) CCS 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. Identify and execute goals aligned with organizational objectives as defined in the GD and CCS cascades. Assume responsibility for ongoing tracking, maintenance and accuracy of metrics, contract documents, and supporting documentation to ensure inspection readiness and compliance with departmental and Johnson & Johnson 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. Identify and promote best practices. Adhere to Standard Operating Procedures (SOPs), ethics and departmental compliance as determined by GD management as well as operating companies, corporate, Health Care Compliance (HCC) and Quality Assurance (QA) guidelines. Develop employees, as applicable, via HR Planning programs including but not limited to Performance and Development Management (PDM) and training to meet current employment opportunities and endorse the value of a diverse work force; Assist in recruiting, managing, coaching/mentoring, workload prioritizing, and evaluating cross-functional staff members. Analyze 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. Analyze investigator grants for fair market value aligned with regional knowledge, compliance guidance and the Johnson & Johnson grant pricing guidelines. Lead the approval escalation of grants as appropriate. Manage Contract Research Organizations (CROs) contracted to negotiate Clinical Trial Agreements (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. Assess risks of budget and legal provisions independently. Provide solution and business focused advice to stakeholders and others within Johnson & Johnson 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 GD management as well as operating companies, corporate, healthcare compliance and QA guidelines and requests for auditors. Exemplary customer focus with vision to drive solutions. Qualifications A minimum of a Bachelor's degree is required. A minimum of 6 years of contract experience in clinical operations with a Pharmaceutical company, Contract Research Organization (CRO) or investigator site is required. Knowledge of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is required. Knowledge of the clinical development process is required. People management experience is preferred. Experience in project management and/or logistics is preferred. Knowledge of databases and/or project management systems preferred. Previous work experience in international and virtual environments preferred. Must have excellent communication and interpersonal skills. Must have strong negotiation, decision-making and problem-solving skills. Must have the flexibility to manage through ambiguity with minimal direction and motivate team members. The ability to handle a high volume of work and meet very aggressive deadlines is required. The ability to collaborate with all levels in a cross-functional team environment. This position will require 10% travel. The anticipated base pay range for this position is $129,500 to $194,000.
Salary Range:
$100K -- $150K
Minimum Qualification
Operations Management, ProcurementEstimated Salary: $20 to $28 per hour based on qualifications.
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