Senior Contracts & Grants Analyst
Johnson & Johnson Family of Companies is currently recruiting for a Senior Contracts and Grants Analyst. The position will be based in Titusville, NJ, Raritan, NJ or Spring House, PA
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The Senior Contracts and Grants Analyst, reporting to the Contracts & Grants Manager, is responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.
Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements.
Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required. (25%)
Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate. (25%)
Work with the global Contracts & Grants team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the Contracts & Grants team and support functions and communicate such to stakeholders. Liaise with Contract & Grants management and functional Contract & Grants support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate. (25%)
Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle. (10%)
Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts. (15%)
Decision-Making and Problem-Solving:
- Adhere to SOPs, ethics and departmental compliance as determined by Global Clinical Development Operations management as well as operating companies, corporate, Health Care Compliance and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with Contracts & Grants Global Clinical Development Operations and operating companies. Comply with requests from QA and auditors.
- Able to work independently as well as in a collaborative team environment.
- Will interface with internal Business Partners (Contracts & Grants, Therapeutic Area, Medical Affairs, Medical Affairs Operations, Global Clinical Development Organization, Janssen Research Procurement, Clinical Development Organization, Health Care Compliance, Risk Management, Legal, etc.) outside parties such as Clinical Investigator Sites, Commercial Suppliers and Clinical Research Organizations (when applicable).
- Bachelor's degree in appropriate scientific or business disciplines.
- 3- 5 years' experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
- Must have a working knowledge of the clinical development process with 3-5 years of negotiation and contract experience.
- Excellent communication skills (both oral and written).
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.).
- Familiarity with clinical research processes.
- Ability to work effectively in cross function teams.
- Strong and proven negotiation and problem resolution skills.
- Working knowledge of PCs (MS Office suite at a minimum) and database management.
- Fluency in English.
- Ability to travel up to 10%.
- Previous experience working in virtual teams.
- Experience in Oncology and with Standard of Care.
United States-New Jersey-Titusville
North America-United States, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
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