REGULATORY HEALTH PROJECT COORDINATOR/MANAGER, GS-0601-12/13


Vacancy ID: 772499   Announcement Number: HHS-FDA-CDER-DE-13-772499   USAJOBS Control Number: 329651500

Occupational/Assessment Questions:

1. Have you 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, such as biology, chemistry, biochemistry, pharmacology, epidemiology, or other related biological and/or medical sciences?

A. Yes and I have submitted my transcripts showing I meet this Basic Requirement.
B. No, I do not meet the educational requirement as described above.

2. Do you have one full year of specialized experience, equivalent to the GS-11 or higher grade level in the Federal Service, coordinating projects and managing project status; using spreadsheet software to retrieve and analyze data; and maintaining working relationships with internal and external customer?

A. Yes (this specialized experience must be reflected in your resume)
B. My experience does not match the description above.

3. Do you have one full year of specialized experience, equivalent to the GS-12 or higher grade level in the Federal Service, managing and/or leading multiple projects that includes coordinating the work activities of team members; applying FDA regulations, drug approval processes, pharmaceutical discovery, and/or drug manufacturing processes; utilizing spreadsheet software to retrieve data and provide up-to-date status of project activities; resolving conflicts that may adversely affect project goals; and establishing and maintaining working relationships with internal and external customer?

A. Yes (this specialized experience must be reflected in your resume)
B. My experience does not match the description above.

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.

4. Participate in drug manufacturing or drug discovery processes in a medical and/or pharmaceutical industry.

5. Advise on drug application and review processes in a medical and/or pharmacy industry.

6. Monitor regulatory affairs for a medical or pharmaceutical industry.

7. Provide up-to-date status of project progress activities to management.

8. Coordinate the project activities of a team including scheduling, milestones, and assignments.

9. Monitor the progress of team activities for an assigned project.

10. Identify issues/concerns that may adversely impact project goals of a project (e.g., scheduling, resources, and risks).

11. Work with members of a scientific, regulatory, and/or management review team to develop project plans.

12. Recommend innovative solutions to improve review processes and activities for a program.

13. Identify and coordinate the resolution of conflicting resource needs, availability, and scheduling for a project.

14. Advise supervisors, team members, and management of potential impact to project situations and recommend innovative solutions to problem areas.

15. Participate in discussions regarding the implementation of new policies, procedures, and processes for a program.

16. Advise supervisors, team members, and management of potential impact to project situations and recommend innovative solutions to problem areas.

17. Provide oral reports or briefings on up-to-date status of a project's progress.

18. Write, edit, and/or review reports on technical policy or procedural issues or changes for a program.

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