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
General Contracts law
Requirements:
Juris Doctor from an accredited law school required along with a State Bar membership.
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 collaborate 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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Job Snapshot
Employee Type
Full-Time
Location
Bethesda, MD
Job Type
Legal
Experience
Not Specified
Date Posted
03/22/2023
Job ID
542/202/1064
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