About the role
Duties
The incumbent of this position will:
- Develop policies and procedures for each program activity related to regulatory projects.
- Represent the office on working groups, and committees whose subject matter is related to generic drugs regulation, as requested.
- Schedule ad hoc meetings on related issues and activities.
- Identify and provide solutions to major, complex, and sensitive issues as well as to problems that have been particularly unyielding to solutions.
- Monitor status of all project activities through interaction with project participants and, as necessary, supervisors and directors.
- Serve as the primary point of contact for up-to-date project status and represent the project team to management.
- Advise management of potential and emerging policy issues and the need to formulate appropriate administrative or program management responses to implement new initiatives.
- Develop project plans, as needed, for each program activity.
- Develop written analyses providing the probable consequences of the various courses of action along with recommendations for action.
- Prepare standard operating procedures and other implementation documents covering any issues involving or impacting on the projects managed.
Qualifications
In order to qualify for **Project Manager GS-0301-14,**you must meet the following:
MINIMUM QUALIFICATIONS:
GS-14: Applicants must have one year of specialized experience equivalent to at least the GS-13 grade level in the Federal service.
ADDITIONAL QUALIFICATIONS:
Specialized experience is defined as managing/leading project teams in planning and executing all phases of work throughout a project life cycle; providing oversight and administration of highly specialized regulatory program activities including but not limited to specialized experience related to premarket and post market safety surveillance of generic drug products, coordinating the activities of projects to include monitoring, tracking, and reporting of information; measuring and improving program operations or management processes and systems; and providing resolutions to team members and/or senior officials on issues or conflicts affecting projects.
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.
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