Specialized Experience Requirement
To be qualified for this position, you must provide evidence of specialized experience in a managerial capacity with responsibility for medical product-related Food and Drug law, such as the development, implementation and/or evaluation of statute, regulations, guidances, and/or other policies related to medical product regulation; making independent legal/regulatory judgments regarding medical product-related issues. This experience must be evidenced by superior written and oral communication skills, experience interacting with one or more of the medical product industries and/or FDA officials, superior strategic, analytical, interpersonal and problem solving skills. Typically, experience of this nature is gained at or above the GS-15 grade level in the Federal service, or its equivalent with state or local government, the private sector, or nongovernmental organizations.
Senior Executive Service Requirements
Unless you are currently serving under a career SES appointment, are eligible for reinstatement into the SES, or have successfully completed a SES Candidate Development Program approved by OPM, you must submit a narrative statement via the assessment questionnaire covering each of the Executive Core Qualifications (ECQs) in order to receive consideration for the position. Current or former career SES employees are not required to address the ECQs, but must address the Technical Qualifications (TQs) in a narrative statement via the assessment questionnaire.
Public Health Service Commissioned Corps Officers interested in applying for this position to serve in the SES must resign their commission, if selected. If you are applying under this option, you must address both the TQs and ECQs in a narrative format in the assessment questionnaire within the announcement. Public Health Service Commissioned Corps Officers interested in performing the duties of the position within the Commissioned Corps must address the TQs in a narrative format within the assessment questionnaire, but are not required to address the ECQs.
Additional information on the proper preparation of ECQs is available by going to the Office of Personnel Management's web site at http://www.opm.gov/ses/references/GuidetoSESQuals_2010.pdf. Applicants are encouraged to follow the Challenge, Context, Action, and Result model outlined in the guide.
When responding to the ECQs, you must clearly show that you possess the experience, knowledge, skills and ability to perform the duties of this position by submitting narrative responses in which you detail your experience in each of the ECQs.
Your examples should be clear and emphasize your level of responsibilities, scope and complexity of programs managed, program accomplishments with results of your actions, policy initiatives and level of contacts. In addition, your responses should highlight your experience, training, and achievements in conjunction with the resume that you provide. You should limit your narrative to two pages per each ECQ, for a total of 10 pages.
In order to satisfy all of the specified requirements, you must submit narrative responses via the assessment questionnaire addressing the TQs and five ECQs outlined below.
- 1. Five years of demonstrated experience working with Food and Drug law as it pertains to medical products (i.e., medical devices, drugs, or biologics).
- 2. Demonstrated management capabilities within a diverse organization, such as overseeing a team of lawyers.
- 3. Superior communication skills.
- 1. Knowledge of current issues and policies associated with the regulation of medical products (i.e., medical devices, drugs, or biologics).
- 2. Skill in identifying, analyzing, managing, solving and providing comprehensive advice on highly complex legal/regulatory issues.
- 3. A law degree from and accredited institution.
Executive Core Qualifications
Fundamental Competencies: The following competencies are the foundation for success in each of the ECQs. Interpersonal Skills; Oral Communication; Integrity/Honesty; Written Communication; Continual Learning; and Public Service Motivation. These Fundamental Competencies are cross-cutting and should be addressed over the course of your ECQ narratives.
1. Leading Change: This core qualification involves the ability to bring about strategic change, both within and outside the organization, to meet organizational goals. Inherent to this ECQ is the ability to establish an organizational vision and to implement it in a continuously changing environment. (Competencies: creativity and innovation, external awareness, flexibility, resilience, strategic thinking, vision)
2. Leading People: This core qualification involves the ability to lead people toward meeting the organization's vision, mission, and goals. Inherent to this ECQ is the ability to provide an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork, and supports constructive resolution of conflicts. (Competencies: conflict management, leveraging diversity, developing others, team building)
3. Results Driven: This core qualification involves the ability to meet organizational goals and customer expectations. Inherent to this ECQ is the ability to make decisions that produce high quality results by applying technical knowledge, analyzing problems, and calculating risks. (Competencies: accountability, customer service, decisiveness, entrepreneurship, problem solving, technical credibility)
4. Business Acumen: This core qualification involves the ability to manage human, financial, and information resources strategically. (Competencies: financial management, human capital management, technology management)
5. Building Coalitions: This core qualification involves the ability to build coalitions internally and with other Federal agencies, State and local governments, nonprofit and private sector organizations, foreign governments, or international organizations to achieve common goals. (Competencies: partnering, political savvy, influencing/negotiating)
The Ethics in Government Act, PL 95-521 requires the applicant selected for this position to submit a financial disclosure statement, SF-278, prior to assuming the SES position, annually, and upon termination of employment. Status applicants must submit a copy of their most recent SF-50, Notification of Personnel Action, which verifies status.
All applicants will be considered without regard to race, color, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, disabling condition, membership in an employee organization, or any other non-merit factors.
All initial appointments to an SES position are contingent on approval from OPM's Qualifications Review Board unless the selectee has successfully participated in an OPM approved SES Candidate Development Program.
In accordance with Federal and Agency Travel regulations, the payment of travel and relocation expenses may be reimbursed for travel, transportation and relocation expenses associated with reporting for duty to this position.
As a condition of employment, all male applicants born after December 31, 1959, must have registered for the selective service. If selected for this position, the applicant must sign a statement certifying his registration, or the applicant must demonstrate exempt status under the Selective Service Law.
Only experience obtained by the closing date of this announcement will be considered.
HOW YOU WILL BE EVALUATED:
Your resume and narrative responses to the technical qualifications and the five Executive Core Qualifications are an integral part of the process for determining your basic and specialized qualifications for the position. Responses that are not supported by your resume will eliminate you from consideration. Your application will be evaluated in the following manner:
1. Application packages will be reviewed for completeness (incomplete or late packages will not receive further consideration).
2. Basic qualifications review. Your resume and questionnaire will be reviewed to ensure that you meet the Specialized Experience Requirement. (If you do not meet this requirement, you will not receive further consideration).
3. Review of your supplemental qualifications document to determine your rating.