Science Policy Analyst

Duties
Duties as a Science Policy Analyst (PMR/PMC Coordinator) include, but are not limited to the following:

• Responsible for assisting with orchestrating the development and implementation, including staff training, of programs and initiatives to support the Center's policies and procedures related to the PMR/PMC program.
• Works with the Associate Director for Safety (ADS) and the PMR/PMC program Project Management Officer to develop and improve the program's policies, processes and procedures, including developing project plans, setting time frames, milestones, and an agreed upon endpoint.
• Monitors and reports actual status of activities within the PMR/PMC program through interaction with program participants and, if required, supervisors and directors.
• Interfaces with OND staff and other components in CDER (e.g., Office of Bioinformatics; Office of Program & Strategic and Analysis) who are involved in establishment, documentation and tracking of PMRs and PMCs to identify user needs and potential solutions to improve PMR/PMC data capture and analysis.
• Analyzes data for and prepares written reports on PMR/PMC status including but not necessarily limited to the status of PMRs/PMCs created since enactment of the FDA Amendments Act (FDAAA); the Annual Report to Congress on the status of the FDAAA 'backlog' of PMRs/PMCs; the Annual Federal Register report on the status of PMRs/PMCs and Annual Reports.
• Coordinates regularly with the PMR/PMC Project Management Officer, division-level staff, and other subject matter experts to keep the systems and templates current.
• Coordinates and/or provides both periodic and special reports pertaining to PMR/PMC tracking, status and external communications (e.g., communications to industry).
• Assists ADS and the PMR/PMC Project Management Officer in enabling OND and other CDER personnel involved in the PMR/PMC program staff to understand and implement the policies and procedures related to PMRs and PMCs.
• Develops and provides training and other educational opportunities for OND and other CDER staff on templates for sponsor letters and memos policies, procedures, regulations, guidance related to PMRs/PMCs.

Qualifications
Basic Education Requirement
Degree: major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position. (You must submit your transcript at time of application submission)

AND

Minimum Requirement
In order to qualify for Science Policy Analyst (PMR/PMC coordinator), GS-0610-14, you must meet the following:
Have one (1) year of specialized experience, equivalent to the GS-13 in the Federal service, that included providing oversight and advice on the management of drug development, regulation and/or safety issues, including those related to Post-marketing Requirements (PMRs) and Post-marketing Commitments (PMCs); analyzing a wide range of technical issues to develop recommendations for resolution of drug development, regulation and/or safety issues, including those related to PMRs and PMCs; coordinating and communicating policies and procedures with a diverse groups of scientists, professionals, and organizations both within and outside the Agency.

Classification & Qualifications General Schedule Qualification Standards:
Documenting experience:
In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

Education
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program.
For further information, click on foreign education.