HHS Careers · 2 days ago

Lead Regulatory and Safety Specialist

Montgomery County, MD

Full-time

Onsite

Senior Level

1+ years exp

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Responsibilities

Provide regulatory guidance, safety oversight, operational support, and inspections to ensure compliance with clinical trial regulations and best practices.

Serve as a Team Lead for internal safety oversight staff and as the COR representative for the safety oversight section of the support contract.

Communicate the organization's strategic plan, mission, vision, and values to the team and integrate them into the team's strategies and goals.

Manage Serious Adverse Event (SAE) reports, Data and Safety Monitoring Board (DSMB), and safety trackers and databases.

Collaborate with Medical Monitors in reviewing, assessing, summarizing, and reporting serious adverse event information.

Qualification

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Regulatory ComplianceClinical TrialsInvestigational New DrugInvestigational Device ExemptionReport PreparationLeadershipGuidance

Required

Bachelor's degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position

At least one year of qualifying specialized experience equivalent to at least the GS-14 level in the Federal Government obtained in either the private or public sector, performing tasks such as providing leadership and guidance on regulatory and safety requirements for clinical trials for Investigational New Drug and Investigational Device Exemption applications, providing guidance on regulations, policies, and procedures governing clinical trials regulatory and safety issues, preparing reports on clinical trials regulatory and safety issues, and providing leadership and direction to other staff in accomplishing work activities