Regulatory Information Specialist

Vacancy ID: 769997   Announcement Number: HHS-FDA-CFSN-DE-13-769997   USAJOBS Control Number: 330124200

Occupational/Assessment Questions:


1. Select one response that demonstrates how you meet the minimum qualification requirement for this position.

A. I have at least one year of specialized experience comparable in difficulty and responsibility to the GS-12 grade level in the federal government (can be obtained in the public or private sector) that equipped me with the knowledge, skills and abilities to perform ALL of the following:  1) determining the interrelationships between regulatory/scientific data elements in information systems in order to plan/organize feasibility studies; 2) conducting experimental theory analysis in accessing, organizing or disseminating regulatory/scientific information, and evaluating conditions and alternatives to existing precedents and procedures that affect these systems; 3) working with system users and computer specialists to develop systems for secure data bases, and determining the need for system enhancements; 4) communicating in writing in order explain scientific and regulatory data elements used, and reporting capabilities on which management decisions can be based; and 5) communicating verbally in order to negotiate with a variety of stakeholders to accept and implement recommendations where proposals involve substantial resources, require extensive changes in established procedures, and conflict with the desires of those whose programs and activities are being impacted. I certify that my resume fully demonstrates my knowledge, skills and abilities to perform the work of this position.

B. I do not meet the qualification requirement defined in response A and do not qualify for this position.


For the following questions, choose ONE statement from the list (A through E) below that best describes your HIGHEST level of work experience in the task. Your answers to these task statements must be supported by your resume or your score may be lowered.

A- I do not have experience in performing this task.
B- I have had education or training in performing this 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 I am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

2. Plan enhancements to database systems.

3. Evaluate database systems effectiveness and determine needs for improvements.

4. Coordinate work to ensure solutions are compatible with existing technologies employed by an organization.

5. Develop tasks to be accomplished by contractors and serve as a project lead to deliver day-to-day instruction and guidance.

6. Review and test enhancements made by contractors as a means of assuring quality control and acceptability of work.

7. Ensure the quality, integrity, and accuracy of regulatory information already in electronic systems and new data entered into systems.

8. Train and orient a variety of individuals (e.g. scientific reviewers, principal investigator's, project management staff, administrative personnel, and managers) on information systems used.

9. Identify and evaluate the needs of reviewers, supervisors, and managers for an organization.


10. Analyze the possible interaction within system hierarchies and between databases.

11. Evaluate the effectiveness of information systems and determine appropriate enhancements/improvements.

12. Determine the need to create methods and procedures for obtaining and storing entirely new types of information regulated by an organization.

13. Determine how interactions of databases and automatic updates/revisions of information contained in multiple parts of computer data systems effect outcomes.

14. Interpret computer errors, operation-related issues, and conduct data backup and recovery.

15. Translate new needs identified into specific requirements to be given to contractors to make actual changes to different systems.

16. Initiate modifications to current information and additions of new information.

17. Develop and support systems to meet identified unique needs using approved development tools and methodologies.


18. Assist with data analysis such as microscopy project results interpretation.

19. Develop checks/access limits for data entry in database systems.

20. Create new modules for electronic systems to meet the reporting needs of an organization.

21. Analyze regulatory review information/data needs of an organization in relation to requirements for regulatory review and scientific information and data needs.

22. Analyze user requirements and identify opportunities that influence existing solutions.

23. Reconcile inconsistencies between older database information placed into an organization's database and new information being placed into the system.

24. Maintain and/or develop network configurations and scientific instruments to run scientific data and manage and archive information.


25. Determine reporting needs of senior managers and ensure periodic and special reports are delivered.

26. Develop written documents that identify and satisfy data reporting needs.

27. Develop written documents that demonstrate the application of scientific disciplines and their interrelationship with each other to recognize the need for changes in systems and processes involved in electronic submission and review.

28. Present data compiled from electronic systems that demonstrate the interaction between scientific and regulatory data elements used to generate reports.

29. Prepare and transmit electronic regulatory submissions.

30. Develop training materials for electronic system use.

31. Prepare reports that identify future trends.


32. Interact with individuals responsible for reviewing and evaluating current software, hardware, and protocol elements and procedures for possible improvements and revision compatible with both individual and organizational goals and objectives.

33. Consult with users to implement required upgrades of operating systems.

34. Explain reporting capabilities of an electronic database system and meanings of the reports generated.

35. Instruct others on types of available reports data, where data comes from in order to be placed in electronic systems, and how data in electronic systems is manipulated to produce needed results.

36. Conduct training on how to internal systems, desktop productivity tools, and data analysis tools.

37. Instruct individuals on accessing internal systems to conduct work and utilize systems to monitor the systems supported activities.


38. Your responses in this Assessment Questionnaire are subject to evaluation and verification.  Later steps in the selection process are specifically designed to verify your responses.  Deliberate attempts to falsify information may be grounds for disqualifying you or for dismissing you from employment following acceptance.  Please take this opportunity to review your responses to ensure their accuracy.  By agreeing to the statement below, you are confirming that you have reviewed your responses to this questionnaire for accuracy, and verify that your responses accurately describe your current level of experience and capability.

Failure to agree to the statement below will disqualify you from further consideration for this position.

A. Yes, I verify that, to the best of my knowledge and belief, all of the information included in this questionnaire is true, correct, and provided in good faith. I accept that if my supporting documentation and/or later steps in the selection process do not support one or more of my responses to the questionnaire that my rating may be lowered and/or I may be removed from further consideration.

B. No, I do not accept this agreement and/or I no longer wish to be considered for this position.