This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band E (GS-15 equivalent).

Duties

Serve as the principal advisor to the Office of Communications Director on all aspects of stakeholder engagement for patients and patient advocacy groups. Engage with internal and external customers to develop complementary, collaborative actions that improve medication use and increase regulatory activities. Provide oversight and execution regarding drug development. Oversee the FDA's Safe Use Initiative responsible for reducing preventable harm drugs. Lead interdisciplinary teams in support of mission and goals. Conduct outreach to the healthcare community, professional organizations, and patient safety and advocacy groups. Supervises contract execution of Broad Agency Agreements to support research aimed to reduce preventable harm from medication misuse and errors. Serve as a representative on committees and conferences on broad policy matters and complex issues related to drug development and regulation. Serve as a first line supervisor providing technical and administrative direction to three or more subordinate employees.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• One-year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• One-year supervisory probationary period may be required.

Qualifications

In order to qualify for the Staff Director position which falls under the 0601 occupational Series, you must meet the following education and relevant years of experience requirements by 11:59 pm EST on 08/09/2024: Basic Education Qualification Requirements: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/general-health-science-series-0601/ General Health Science Series 0601, General Medical and Healthcare Series, 0601, Individual Occupational Requirements Basic Requirements: EDUCATION: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. Clarification from the agency regarding qualifying degrees for the General Medical and Healthcare, 0601 series: Professional work requires knowledge in a field of science or learning characteristically acquired through education or training equivalent to a bachelor's or higher degree with major study in or pertinent to the specialized field, as distinguished from general education. Work is professional when it requires the exercise of discretion, judgment, and personal responsibility for the application of an organized body of knowledge that is constantly studied to make new discoveries and interpretations, and to improve data, materials, and methods. Medical Fields: medicine, dentistry, podiatry, optometry, chiropractic, pharmacy and veterinary medicine. It also means applications or products for the diagnosis, treatment, mitigation or prevention of a physical or mental disease, disorder or abnormal state, or its symptoms, where such applications or products are approved by or subject to the approval of the U.S. Individuals in the medical fields are licensed professionals who have advanced or medical degrees. The term "medical" relates to or is concerned with physicians or the practice of medicine. Health Sciences Fields: an interdisciplinary field that involves applying concepts from the natural and social sciences to health-related topics such as medicine, nutrition, environmental health, disease, and healthcare. Health sciences are those sciences which focus on health, or health care, as core parts of their subject matter. It deals with human and animal health. It also involves applying scientific research to clinical practice, in effort to improve healthcare for patients and communities. Health sciences relate to multiple academic disciplines, including, disciplines in the life sciences, physical sciences, engineering, mathematics, computer science, the health sciences, and emerging patient safety disciplines (such as social care research). Generally speaking, an undergraduate degree in health sciences prepares an individual for employment as a technician (e.g., cardiovascular technician, surgical technician, anesthesia technician, medical lab technician, veterinary technician, pharmacy technician, etc.), assistant (e.g., occupational therapy assistant, etc.), dental hygienist, paramedic, etc. Allied Sciences Fields: Broad fields of health-care professions made up of specially trained individuals (such as physical therapists, dental hygienists, audiologists, and dietitians) who are typically licensed or certified but are not physicians, dentists, or nurses. Generally speaking, an undergraduate degree in Allied Health Sciences prepares an individual for immediate employment in a variety of health fields including case management/patient care coordination, health education, medical billing and account management, health marketing and sales, laboratory research, health insurance administration. Allied subjects are upper-division math, science, or engineering courses that have a background connection or relevance to chemistry. Here are a few examples of how disciplines in engineering, mathematics, data science, etc. may be used in realm of health sciences. These examples are not all inclusive. For example, engineering professionals lead or participate in research and development of cutting-edge technologies for new drugs (including drug discovery, design, development, and delivery) and advanced medical procedures for the prevention, diagnosis, treatment, and management of illnesses. Other examples include, but are not limited to, institutions which enable students to explore the health sciences while earning a degree in environmental engineering. Math is a crucial part of medicine since all the graphs, equations, statistics, and general mathematics learned help us to understand important aspects of human and veterinary medicine, biology, and science in general. Data Science helps in the recognition of scanned images to figure out the defects in a human body for helping doctors make an effective treatment strategy. AND, RELEVANT YEARS OF EXPERIENCE: Applicants must meet one of the following education and relevant years of experience combinations to qualify for this AD-0601 Band E (GS-15 equivalent) position: A bachelor's degree and also have 5 years of relevant experience serving as a leader in a complex organization managing, planning, directing, and evaluating multidisciplinary activities of significant scope and effect; building strong working relationships among external organizations/customers with diverse interests and/or opinions, such as, professional, public health, patient safety or patient/consumer organizations, or other federal agencies; identifying strategic objectives in support of organizational mission and objectives; leading staff towards reaching established goals; and, managing projects within a health or regulatory organization. OR, A master's degree and also have 4 years of relevant experience serving as a leader in a complex organization managing, planning, directing, and evaluating multidisciplinary activities of significant scope and effect; building strong working relationships among external organizations/customers with diverse interests and/or opinions, such as, professional, public health, patient safety or patient/consumer organizations, or other federal agencies; identifying strategic objectives in support of organizational mission and objectives; leading staff towards reaching established goals; and, managing projects within a health or regulatory organization. OR, A Doctorate, J.D., MD, DO, DDS, DPM, or DVM degree and also have 2 years of relevant experience serving as a leader in a complex organization managing, planning, directing, and evaluating multidisciplinary activities of significant scope and effect; building strong working relationships among external organizations/customers with diverse interests and/or opinions, such as, professional, public health, patient safety or patient/consumer organizations, or other federal agencies; identifying strategic objectives in support of organizational mission and objectives; leading staff towards reaching established goals; and, managing projects within a health or regulatory organization.

Education

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Transcripts must reflect a degree conferred date and major concentration of study.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents.

Foreign Education: 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; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

1. National Association of Credential Evaluation Services (NACES)
2. Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Contacts

• Address FDA Center for Drug Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD 20993 US
• Name: FDA Applicant Help Desk
• Phone: 866-807-3742
• Email: [email protected]