Manage the drug review process for one or more classes of drugs.
Plan, focus and coordinate team activities within the Division.
Plan and organize the work of the review teams to accomplish a variety of concurred activities performed in several organizations.
Serve as the point of contact for all communications concerning applications in the assigned drug classes.
Applicants must have successfully completed a full four-year course of study at an accredited college or university leading to a bachelor's or higher degree that included a major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.
In addition to the basic qualification requirement described above, the following additional education and/or experience are required. Transcripts must be provided with your application for qualifications based on education. Your application or resume must clearly show that you possess the specialized experience requirements.
Specialized experience is defined as experience that is typically in or related to the work of the position to be filled and has equipped the applicant with the particular knowledge, skills, and abilities to successfully perform the duties of the position.
GS-12: Applicant must have one year of specialized experience equivalent to at least the GS-11 grade level in the Federal service.
Specialized experience is defined as experience serving as a project manager reviewing and evaluating regulatory requirements for the drug application process.
GS-13: Applicant must have one year of specialized experience equivalent to at least the GS-12 grade level in the Federal service.
Specialized experience is defined as experience coordinating or leading scientific projects in collaboration with regulatory staff and multidisciplinary, matrix designed teams, to include clinicians, chemists, biologists, toxicologists, pharmacologists, and/or statisticians, in the drug review process; and ensuring legal, regulatory and policy requirements/compliance associated with drug development.
Grade (Salary) Levels:
Federal General Schedule (GS) grade levels at which Regulatory Health Project Managers are commonly filled are:
Regulatory Health Project Managers are located at HQ (suburban Washington, D.C.)