Vacancy ID: 770403   Announcement Number: HHS-FDA-CDER-DE-13-770403   USAJOBS Control Number: 329247200

Occupational/Assessment Questions:

1. Please read the following statements carefully and select the one response that best describes your education as it pertains to the Basic Requirement for this position. You must select one response. If your answer is 'A' below, you must provide a copy of your college transcript.

A. I have successfully completed a full four-year course of study in an accredited college or university leading to a bachelor's or higher degree with a major study in an academic field related to health sciences or allied sciences appropriate to the work of the position. (You must submit a copy of your college transcripts).
B. I do not meet the educational requirement as described in 'A' above.

2. Do you have one full year of specialized experience, equivalent to the GS-11 or higher grade level in the Federal Service, that included: identifying and resolving project problems (i.e. resource needs, conflicts, availability of staff, and scheduling) and participating in planning and organizing the work of a working group?

A. Yes (Your experience must be evident in your resume).
B. No

For each of the following task statements, select one response below (A-E) that best describes your experience level.

A- I have no experience in performing this work behavior.
B- I have limited experience in performing this work behavior. I have had exposure to this work behavior but would require additional guidance, instruction, or experience to perform it at a proficient level.
C- I have experience performing this work behavior across routine or predictable situations with minimal supervision or guidance.
D- I have performed this work behavior independently across a wide range of situations. I have assisted others in carrying out this work behavior. I seek guidance in carrying out this work behavior only in unusually complex situations.
E- I am considered an expert in carrying out this work behavior. I advise and instruct others in carrying out this work behavior on a regular basis. I am consulted by my colleagues and/or superiors to carry out this work behavior in unusually complex situations.

3. Review drug applications for compliance with legal, regulatory, and policy requirements.

4. Manage the activities in the drug review process from the initial submission to the time of approval.

5. Establish schedules and milestones to achieve review goals, assuring the timely completion of project activities.

6. Prepare issued-based agendas for all members of a working group prior to meetings.

7. Analyze the review status of various drug applications with respect to variances from project plans.

8. Identify project activities or situations that may adversely impact the project plan.

9. Monitor and report the status of activities within an assigned project.

10. Recommend solutions to resolve scheduling issues of distributed work among a working group. 

11. Provide authoritative advice to all parties engaged or interested in the drug review process.

12. Collaborate with all members of a review team to develop project plans and set time frames.

13. Serve as the primary point of contact for the up-to-date status of project progress.

14. Negotiate timely resolution of scientific and regulatory conflicts or problems to avoid delays in achieving project goals.

15. Write, edit, and/or review official correspondence regarding action, policy issues or requests for additional information.

16. Develop issue based meeting agendas and official meeting minutes.

17. Develop briefing papers and memos to provide upper level management with up-to-date status.