Top 1 Regulatory affairs specialist Jobs in Gaithersburg Md

Regulatory Affairs Specialist - VESPER
Henry M. Jackson Foundation —Washington, DC
- $67,500 - $82,000 a year
- Full-time
- Hybrid work
- HIPAA
- Mid-level
- Health insurance
- Dental insurance
1d

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Regulatory Affairs Associate II
Frederick National Laboratory —Rockville, MD
A bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical…
$69,800 - $100,045 a year
Manager, Regulatory Affairs - Advertising and Promotion
Supernus Pharmaceuticals Inc —Rockville, MD
Pharm.D. and no experience, master’s with four years, or a bachelor’s with five years of relevant experience in Pharmaceutical Regulatory Affairs.
$100,000 - $140,000 a year

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Regulatory Affairs Specialist - VESPER

Henry M. Jackson Foundation -
Washington, DC

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Job Details

Full-time
$67,500 - $82,000 a year
1 day ago

Benefits

Health insurance
Dental insurance
Vision insurance
Retirement plan

Qualifications

Document compliance management
Informed consent
HIPAA
Mid-level
Research project coordination
Records management
Informed consent procedures implementation
Health information regulatory compliance
Research compliance clinical trial records management
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Research budget management
Ethical review application preparation
Budget review
Inventory tracking
Research compliance quality assurance records management

Full Job Description

Join the HJF Team!

HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). This is the second Regulatory Affairs level in the series.

This position will be in support of the Complex Exposure Threats Center of Excellence (CETCE) at the VA Medical Center in Washington, DC. The Regulatory Affairs Coordinator will support the center’s human subjects research portfolio focused on environmental exposures and health outcomes, by preparing, submitting, and managing regulatory documentation; ensuring compliance with institutional, federal, and sponsor requirements; and assisting with study budget and supply management. This role is responsible for Institution Review Board (IRB) submissions, informed consent oversight, regulatory documentation management, supply tracking, ongoing study compliance, supply inventory, and study budget oversight. The position works closely with investigators, study coordinators, and the DC VA medical center’s IRB team to ensure timely approvals and efficient study operations.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

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Regulatory Affairs Specialist - VESPER

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