1. Have you successfully completed a full four-year course of study 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.
2. Do you have at least one full year of specialized experience, equivalent to the GS-11 or higher grade level in the Federal service, that included coordinating the activities of projects to include monitoring, tracking, and reporting of information; applying FDA regulations, policies, and legislations in conducting new product/drug approval processes; and using spreadsheet software to retrieve and analyze data?A. Yes, I have the experience described above.
3. Do you have at least one year of specialized experience, equivalent to the GS-12 or higher grade level in the Federal service, that included managing and/or leading projects to include managing resources, assigning work, and resolving conflicts; and providing advice and guidance on FDA regulations, policies, and legislations relating to new product/drug approval processes?A. Yes, I have the experience described 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.
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. 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.