PDF versionJob Summary
This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of the Commissioner (OC), Office of Clinical Policy and Programs (OCPP), Office of Combination Products (OCP) located in Silver Spring, MD.
Major Duties
- Ensures the regulations and policies developed in the assigned areas are consistent with statutory requirements and existing policy and that their need is justified.
- Serves as a member of inter-agency task forces and study groups tasked to identify problems, recommend solutions or provide direction in the area of study.
- Resolves a broad range of issues concerning the application of any of FDA?s enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government.
- Prepares replies to correspondence from the regulated community and other interested persons on issues that are industry wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy.
- Provides consultation and expert advice on scientific and policy issues in the area of study to various agencies, foreign governments, international organizations, and FDA.
Qualifications
The position of Biologist falls within the 0401 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 11/25/2019. In addition to meeting Time-in-Grade requirements above, you must also meet the following Basic Education Requirement AND Specialized Experience Requirement below: Basic Education: Have a degree in biological sciences, biology, engineering, chemistry, or related disciplines appropriate to the position; OR Have a combination of education and experience: Courses equivalent to a major, as shown above, plus appropriate experience or additional education. AND Specialized Experience: Have one year of specialized experience, equivalent to the GS-13 grade level in the Federal service, developing and implementing scientific regulatory policies that affect the regulation of combination products (i.e., therapeutic and diagnostic products that combine a drug, device, and/or biological product); researching controversial scientific-regulatory issues, analyzing and recommending solutions and/or corrective actions. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login,select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. You must submit supporting documentation to verify your eligibility to apply for this vacancy.
For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question. See the Required Documents section for full details...
Pay Range
$117,191.00 - $152,352.00