Social Science Analyst
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
View full vacancy announcement here: https://www.fda.gov/media/158321/download
Application Period: May 9, 2022-May 19, 2022
Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Position: Social Science Analyst
Series: AD-0101
Location(s): Silver Spring, Maryland
Work Schedule: Full Time
Salary: Starting at $126,233
Cures Band(s): Band D
Full Performance Band Level: Band D
Travel Requirements: 25% or less
Bargaining Unit: 3591
Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
OND is a multi-disciplinary organization engaged in the oversight of human drug trials in the United States, in review of new drug applications (NDAs) and biologics license applications (BLAs) for marketing drugs and therapeutic biologics in this country, and over the counter (OTC) drug products.
Duties/Responsibilities
As a Social Science Analyst, the incumbent is responsible for developing policies, strategies, and plans for social science analysis of over-the-counter (OTC) regulations, effective labeling communications, and ensuring positive communications for these areas are shared with CDER and the industry. Specific duties are as follows:
- Serves as an expert advisor and technical authority on complex and precedent-setting policy and program issues, developing policies, strategies, and plans for Social Science analysis programs/projects for agency-wide application. Serves as a lead in writing guidance for Industry that address social science issues that pertain to the OTC drug development process.
- Provides specialized expertise in designing and monitoring policies, strategies, and programs in the Social Science Analysis area.
- Reviews and evaluates a variety of complex label comprehension studies, self-selection studies, and actual use protocols to determine if they are well-designed and adhere to the (OTC) regulations. Determines whether average and low literacy consumers, and other sub-groups, adequately understand the information on the tested Drug Facts label(s) and can appropriately self-select to use the drug product. Analyzes data from actual use studies to determine whether consumers are likely to use the OTC drug product appropriately in the OTC setting.
- Contributes to the development and design of the language for prescription-to-OTC switch product labels so that these labels clearly communicate the information that consumers must understand and contains all relevant medical information necessary to insure safe and effective use of the product and follows the Drug Facts Format.
- Collaborates to apply novel and state-of-the-art information and insights from the social science research literature to government policy decision-making and communications.
- Acts a liaison and works with stakeholders to apply current information and insights from social science and measurement research to advance government policy decision making and communication as related to study endpoints, including developments and assessment of new communication tools as needed.
Qualifications
To be placed into a Cures position, candidates must meet the following criteria:
- Scientific, Technical, and Professional Fields
- Qualified and Outstanding Candidates
- Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
- Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
Education Requirement:
Social Science Series, 0101
Degree: behavioral or social science; or related disciplines appropriate to the position.
or
Combination of education and experience that provided the applicant with knowledge of one or more of the behavioral or social sciences equivalent to a major in the field.
or
Four years of appropriate experience that demonstrated that the applicant has acquired knowledge of one of more the behavioral or social sciences equivalent to a major in the field.
Professional Experience:
- Skill in applying critical thinking and problem-solving skills. Ability to identify and analyze problems; weigh relevance and accuracy of information; generate and evaluate alternative solutions; and make recommendations.
- Experience making decisions or recommendations significantly changing, interpreting, or developing important public policies or programs in a professional or administrative field.
- Experience and knowledge utilizing data gathering methods and analytical/evaluative techniques to conduct assessments of health communication strategies and to draw valid conclusions.
Desired Professional Experience:
The ideal candidate will possess:
- Experience and knowledge with FDA regulations and laws, historical and legal precedents, regulations, guidelines, policies, and procedures pertaining to medical product development
- Skill in communicating with diverse audiences, both orally and in writing.
- Ability to work independently and proactively identify priorities and complete assignments with minimal oversight.
- Experience applying project management techniques and concepts to manage large, complex projects with diverse stakeholders.
How to Apply
Submit resume or curriculum vitae with cover letter to ONDIORecruitment@fda.hhs.gov by May 19, 2022. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact Natasha Townsend. Please reference Job Reference ID: B-22-126
Announcement Contact
For questions regarding this Cures position, please contact Natasha Townsend, Natasha.Townsend@fda.hhs.gov.
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate.