・Assist and learning to lead & 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/GCDO 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 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.
・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.
・Identify and execute goals aligned with organizational objectives as defined in the GCDO and C&G 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 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. Identify and promote best practices.Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as operating companies, corporate, HCC and QA guidelines
・Develop employees, as applicable, via HR Planning programs including but not limited to Performance & 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.
・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.
・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.
・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 and requests for auditors.
・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 10% of the time.資格
・Bachelor's degree or equivalent in appropriate scientific or business disciplines, masters degree and/or MBA preferred
・Candidate is required to have 6 years of experience in clinical development with a pharmaceutical company or CRO or investigator site
・Previous experience in investigator site contracting preferred
・Understanding of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
・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
・Knowledge of databases and/or project management systems is a plus
・Flexibility to manage through ambiguity with minimal direction and motivate team members a must
・Previous work in international and virtual environments desirable
・Previous people management experience preferred
・Excellent communication skills required
Janssen Pharmaceutical K.K. (7195)ジョブ