Profile

Jessica provides clients with legal and regulatory support needed to design and implement regulatory strategies to advance products, including pharmaceuticals, medical devices, food products, and dietary supplements, through the premarket approval regimen of the U.S. Food and Drug Administration (FDA) and its European counterparts.

Experience

Representative Matters

  • Assists in the drafting and technical review of clinical trial, preclinical testing protocols, and contracts and agreements associated with these activities.
  • Draft Investigational and New Drug Applications, and assists in the planning, drafting, and submission of FDA meeting and information requests, fast track designations, and orphan drug designations.
  • Draft premarket applications for medical devices, including 510(k) applications and De Novo classification requests, and provide technical support for medical device development issues.

Professional Experience

  • Executive Director, Legal/Regulatory/Compliance, CorMedix Inc. (2019-2021)
  • Law Clerk (2019), Regulatory Scientist (2012-2019), Private law practice
  • Graduate Assistant, New York University School of Medicine, Department of Environmental Medicine (2006-2012)
  • Clinical Information Manager, Alpha Physicians Resources (Emergency Medical Associates of NJ) (2004-2012)

Affiliations

  • American Bar Association

Credentials

Education

J.D., cum laude, The Catholic University of America Columbus School of Law

Ph.D., New York University

M.S., New York University

B.A., Ithaca College

Bar and Court Memberships

  • District of Columbia Bar
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