Montgomery County, MD27 days ago
In addition, to qualify for a Regulatory Affairs Specialist GS-0601 position at the GS-13 grade level, you must have: at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: (1) Leading protocol navigation activities, including coordinating scientific review, Institutional Review Board (IRB) and/or Investigational New Drug (IND) submissions, addressing stipulations, and facilitating clinical trial protocol development processes; (2) Managing a clinical trials portfolio by liaising with investigators/ study teams, regulatory agencies, and sponsors; tracking reviews of all review bodies; and maintaining accurate essential regulatory documentation; (3) Developing regulatory documents such as protocols, consents, and associated components in accordance with federal regulatory requirements; (4) Providing regulatory expertise by analyzing complex issues, preparing safety, annual, and/or progress reports, and recommending strategies to ensure compliance and expedite review processes. Assist all aspects of the protocol lifecycle including scientific review, initial investigational new drug (IND) documents, institutional review board (IRB) submission of protocols, continuing review applications, protocol amendments, annual reports to other regulatory and safety bodies such as the Radiation Safety Committee (RSC) and the Institutional Biosafety Committee (IBC), and protocol inactivation.