J&J Family of Companies Lead Contracts and Grants Analyst in Columbia, South Carolina
Janssen Research & Development, LLC, a division of Johnson & Johnson's Family of Companies is recruiting for an Lead Contracts and Grants Analyst, which may be located in Titusville, NJ, Raritan, NJ, Springhouse, PA or Horsham, PA with consideration given to working remotely within the United States.
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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
You will be responsible for the development and analysis of site contracts including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials. The lead will assist with training of staff, facilitating clear and concise communications and assist CGAs with resolution of contracting and study related issues. In addition, the lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the pricing, planning, execution and control of contracts.
Prepare, negotiate, and finalize research support agreements for investigator initiated and collaborative studies through direct negotiation with Institutions. Responsible for delivery on established targets/measurements.
Responsible for analyzing requirements and translating into appropriate contracts and budgets as well as other relevant documents. Responsible for reviewing study specific tracking requirements for accuracy and completeness as well as delivering against contracting cycle time targets
Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the J&J pricing guidelines. Participate in and/or lead approval escalations as appropriate
Provide specialized support and guidance on negotiations for contract documents, as required. Determine potential needs for contract amendments and manage amendment lifecycle. Ensure that contractual terms and provisions comply with corporate process, systems, and strategies.
Provide project management oversight, inclusive of training and supervision to ensure adherence to timelines/targets.
Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.
Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
A minimum of a Bachelor’s degree in appropriate scientific or business disciplines is required, an advanced degree is preferred
A minimum of five (5) years of related business experience within a regulated industry is required
A minimum of two (2) years of experience of contract negotiation within the clinical and/or drug development process is required
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is required
Comprehensive knowledge of clinical research processes is required
Ability to work effectively in cross functional teams is preferred
Working knowledge of PCs (MS Office suite at a minimum) is required
Experience using Sharepoint is preferred
Experience with database management is preferred
Ability to accomplish substantial tasks with minimal supervision is required
Previous experience working in virtual teams preferred
Ability to travel up to 10% of the time domestically and/or internationally is required
United States-New Jersey-Titusville-
North America-United States, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)