Senior Counsel Clinical Trials

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Senior Counsel, Clinical Trials
Duties: Providing legal support and regulatory guidance to internal business partners to facilitate the early development clinical trial-related contracting, sponsor or investigator-initiated study agreements, collaborative research, and various vendor agreements supporting clinical research. Drafting and reviewing clinical research arrangements, Master Services Agreements, Statements of Work, Confidentiality Agreements, CRO and other clinical research related vendor agreements. Identifying business and legal risks while providing solutions to balance legal issues and business objectives.Developing a deep understanding of the business and operational goals while developing and maintaining positive relationships with internal clients at all levels of the organization.Collaborating with internal clients to provide advice on legal issues and driving projects to completion. Partnering with other attorneys and partners on contractual arrangements, legal and regulatory compliance, and general corporate legal issues. Developing regulatory strategies for innovative technologies, and assisting clients in executing those strategies to achieve regulatory compliance and business goals. Providing counsel on FDA regulations, submissions, approvals, and clearance and marketing issues. Advising on licensure, credentialing and privileging, online prescribing, and corporate practice of medicine matters. Providing guidance on Medicare and Medicaid reimbursement and innovative payment systems to drive technology adoption. Drafting clinical trial agreements, and advising on risk management during clinical trials. Providing counsel on compliance with the Stark Law, the Anti-Kickback Statute, and other federal and state fraud and abuse laws. Drafting and reviewing contracts for digital health products and services.

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