Policy Advisor


Vacancy ID: 843194   Announcement Number: HHS-FDA-DE-13-843194   USAJOBS Control Number: 339544400

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 843194
1. Title of Job

Policy Advisor
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 14.


14

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 Policy Advisor

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


241450031 Silver Spring, MD

22. Transition Assistance Plan

If you are applying by the OPM Form 1203-FX, leave this section blank.

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

1. From the descriptions below, select the one which best describes your experience which meets the Minimum Qualification Requirements for Policy Advisor, GS-0301-14.

A. I have one year of specialized experience, equivalent to the GS-13 grade level in the Federal service, providing advice on the development of regulatory and/or enforcement policy concerning FDA laws and regulations.
B. I do not possess the experience described above.

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

2. Interprets and applies legislation, including recently passed device-related provisions of Food and Drug Administration Safety and Innovation Act (FDASIA).

3. Develops, revises, or reviews policy documents, such as regulations, guidance documents, and reports related to legal and regulatory policies.

4. Recommend changes to policies and procedures to ensure timely issuance of appropriate compliance and guidance documents.

5. Advises organization staff by applying knowledge of the Federal Food, Drug and Cosmetic act, and other pertinent laws and regulations, in development, review and evaluation for documents related to medical devices to identify areas of concern and determine conformance with these laws.

6. Assists other organizations in determining, whether concepts for regulations, guidance documents, and other information disseminations raise legal or policy concerns and provides counsel for addressing those concerns.

7. Provide legal guidance to an organization on emerging public health concerns and other sensitive issues.

8. Represents an organization in meetings and conference with various stakeholders.

9. Attends and participates with industry and trade groups in the presentation of legal groups in the presentation of legal and regulatory requirements.

10. Meets with other organizations in industry to discuss resolution of regulatory issues.

11. Participates in briefings of Congressional members and staff.

12. Develops, writes, and reviews high quality reports and other policy documents intended for consumption by multiple stakeholders, high-level administration agency and administration officials, and legislators.

13. Analyze quality techniques and best practice models to resolve a program's customer service issues.

14. Develop indicators to provide objective evidence of the effectiveness of quality procedures and controls within a program area.