Legal Advisor

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Legal Advisor
The candidate will draft and negotiate Clinical Trial Agreements and other research agreements between the government client (NIH) and industry collaborators (biologic and drug product manufacturers), and/or between or among other key parties (CRO, site, etc.). Provide counsel on FDA laws and regulations, ICH, GCP, Intellectual property, Access to data, Ownership of data and specimens, Safety reporting, Participant privacy, Liability, Indemnification, Confidentiality, Human subjects protection, and General Contracts law. A Juris Doctor from an accredited law school is required along with a State Bar membership. Should have 3-5 years of experience working at CRO or in health services. Sound legal judgment. Excellent writing/drafting and verbal communication skills. Strong team player who excels in a collaborative environment. Ability to set and manage priorities and quickly adapt to changes. Self-directed organizational abilities and proven high attention to detail. Ability to solve complex issues using professional creativity and problem-solving skills.

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