Senior Regulatory Counsel - Office Of Clinical Policy And Programs (Ocpp)
Current
Jun 2023 - Present
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David Markert Email & Phone Number
Senior Regulatory Counsel at FDA
at
FDA
1 work email found
@fda.gov
2 phones found area 301 and 202
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Senior Regulatory Counsel at FDA
Location
Rockville, Maryland, United States
Who is David Markert? Overview
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David Markert is listed as Senior Regulatory Counsel at FDA at FDA, based in Rockville, Maryland, United States. AeroLeads shows a work email signal at fda.gov, phone signal with area code 301, 202, and a matched LinkedIn profile for David Markert.
David Markert previously worked as Senior Regulatory Counsel - Office of Clinical Policy and Programs (OCPP) at Fda and Senior Regulatory Counsel - Office of Clinical Policy (OCLiP) at Fda. David Markert holds J.D. from Georgetown University Law Center.
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{first}.{last}@fda.gov
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Profile bio
About David Markert
As a Senior Regulatory Counsel at FDA, I advise Agency leadership and staff on policy matters related to human subjects protection and the regulation of human drugs under the Federal Food, Drug, and Cosmetic Act. I am a problem solver with strong writing and advocacy skills. I have authored or contributed to numerous FDA documents (e.g., regulations, guidance documents, citizen petition responses) concerning drug development, drug supply chain security, and clinical trial transparency, among other issues. I also have a deep background in environmental law, with significant experience counseling clients on pesticides, electronic waste, and Clean Air Act issues.
Listed skills include Legal Writing, Administrative Law, Litigation, Environmental Awareness, and 20 others.
Current workplace
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9 roles
David Markert work experience
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Senior Regulatory Counsel - Office Of Clinical Policy (Oclip)
• Agency policy lead on ClinicalTrials.gov matters, providing regulatory support to FDA staff tasked with enforcing the clinical trial registration and results information reporting requirements set forth in section 402(j) of the Public Health Service Act and its implementing regulations.• Advise OCLiP leadership on development of proposed and final rules relating to the protection of human subjects participating in FDA-regulated research.• Provide technical assistance on proposed legislation concerning ClinicalTrials.gov, good clinical practice, human subject protection, and other matters within FDA’s jurisdiction.
Nov 2019 - Jun 2023
Senior Regulatory Counsel - Cder Office Of Regulatory Policy
• Advised CDER leadership and staff on matters relating to investigational new drug applications, drug supply chain security, tobacco products, and compliance with the National Environmental Policy Act.• Wrote responses to citizen petitions pertaining to FDA’s regulation of human drug products, with a focus on petitions concerning the safety and effectiveness of generic drug products.• Reviewed and commented on rules, guidance documents, responses to congressional inquiries, and controlled correspondence drafted by other offices within CDER.• Represented CDER’s interests in an Agency-wide working group that developed a jurisdictional framework for products made or derived from tobacco.• Implemented programs and projects to identify, assess, and address issues in the areas of drug quality, safety, and supply chain security.
Sep 2012 - Nov 2019
Associate
• Provided guidance and legal interpretation in matters involving the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Food Quality Protection Act, Occupational Safety and Health Act, and various other federal environmental, health, and safety laws. Counseled clients on the propriety of federal agency actions under the Administrative Procedure Act.• Litigated environmental cases involving the Clean Air Act, Endangered Species Act, and FIFRA. Assisted in developing litigation strategies and drafting pleadings, dispositive pretrial motions, and appellate briefs. Supervised the work of junior attorneys and litigation support staff, and negotiated discovery disputes and various other issues with opposing counsel.• Evaluated the potential impact on clients of proposed rules issued by the U.S. Environmental Protection Agency (EPA), Pipeline and Hazardous Materials Safety Administration, and other federal agencies. Worked with other attorneys and client personnel to plan and draft written comments on proposed rules.• Represented pesticide manufacturers and distributors in enforcement proceedings initiated by EPA and state regulatory bodies. Helped negotiate stipulated penalties in settlement of enforcement actions.• Advised a joint-venture of major electronics manufacturers on a variety of legal and policy issues related to the establishment and operation of electronic waste recycling programs. Drafted customer and supplier contracts and made recommendations on corporate governance matters to the client’s management team.• Worked extensively with scientific experts and consultants in the areas of economic analysis, public health, risk assessment, and occupational exposure.
May 2006 - Sep 2012
Summer Law Clerk
• Researched and wrote memoranda in connection with a Freedom of Information Act (FOIA) lawsuit against the Department of Energy concerning the deliberations of the National Energy Policy Development Group.• Analyzed National Pollutant Discharge Elimination System (NPDES) compliance reports to determine if the facilities identified in the reports were susceptible to civil suits under the Clean Water Act.
May 2004 - Aug 2004
Research Associate
• Advised the Executive Director on CRI’s involvement in a coalition of businesses and environmental groups tasked with analyzing the cost-effectiveness of beverage container recovery programs.• Assisted with drafting state beverage container recycling legislation.• Conducted research on the impact of beverage container deposits on overall litter composition and cleanup costs.• Analyzed the beverage container market to determine trends in container size, material, and recycling.• Maintained CRI's technology infrastructure and updated the content of CRI's website.• Handled requests for beverage container recycling information.
Apr 2001 - Sep 2002
Manager
Jan 2000 - Mar 2001
Information Management Leadership Program Associate
Mar 1999 - Dec 1999
Technology Solutions Analyst
Oct 1997 - Feb 1999
2 education records
David Markert education
J.D.
Georgetown University Law Center
Bachelor Of Science (B.S.), Civil Engineering
Cornell University
FAQ
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What company does David Markert work for?
David Markert works for FDA.
What is David Markert's role at FDA?
David Markert is listed as Senior Regulatory Counsel at FDA at FDA.
What is David Markert's email address?
AeroLeads has found 1 work email signal at @fda.gov for David Markert at FDA.
What is David Markert's phone number?
AeroLeads has found 2 phone signal(s) with area code 301, 202 for David Markert at FDA.
Where is David Markert based?
David Markert is based in Rockville, Maryland, United States while working with FDA.
What companies has David Markert worked for?
David Markert has worked for Fda, Wiley Rein Llp, Natural Resources Defense Council, Container Recycling Institute, and Adjoined Consulting.
How can I contact David Markert?
You can use AeroLeads to view verified contact signals for David Markert at FDA, including work email, phone, and LinkedIn data when available.
What schools did David Markert attend?
David Markert holds J.D. from Georgetown University Law Center.
What skills is David Markert known for?
David Markert is listed with skills including Legal Writing, Administrative Law, Litigation, Environmental Awareness, Arbitration, Regulations, Environmental Law, and Appeals.
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