Social Science Analyst

Are you making a difference contributing to the public health and well-being of millions of Americans? Would you like to? The physicians, scientists and other dedicated professionals at the U.S. Food & Drug Administration, Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), located in Silver Spring, MD, contribute to the public health of millions of Americans every day. We pride ourselves on our dedicated and skilled staff and are always looking for committed individuals to help us achieve our mission. OND’s public health mission is to protect and enhance the health of the public through the review and evaluation of scientific data submitted by pharmaceutical manufactures in support of new drug and investigational new drug applications, and to determine if candidate drugs are safe and effective.

The Office of Nonprescription Drugs (ONPD) oversees the development, review, and regulation of nonprescription products. The Division of Nonprescription Drugs II (DNPD II) coordinates, reviews, and decides on the appropriate action for New Drug Applications (NDAs), Over the Counter (OTC) drug monographs, and Investigational New Drug (IND) submissions for nonprescription drug products. DNPD II develops and implements standards for the safety and effectiveness of nonprescription drug products, as well as develops the scientific basis for rulemaking regarding the regulation of OTC monograph drugs. The mission of the DNPD II is to protect the public health by ensuring the safety, efficacy, and security of nonprescription products for human use.

As a Social Science Analyst, you will evaluate a variety of complex label comprehension, self‐selection, and actual use study protocols to determine if they are well‐designed and adhere to nonprescription regulations and analyze the results of these studies. Under direction from the supervisor, you will review and provide advice to stakeholders (including FDA decision‐makers, medical product sponsors and instrument developers) on label comprehension studies, self‐selection studies, and actual use studies used in nonprescription product development collaboratively as part of a multidisciplinary team inclusive of clinical, interdisciplinary scientist, and biostatistical experts.

As a Social Science Analyst, you will have the opportunity to:

• Advance the public health through new drug development.
• Experience training and research opportunities.
• Interact with medical product sponsors.
• Work with a wide range of scientific disciplines in a team-oriented atmosphere.

SALARY & BENEFITS

• Salary is commensurate with experience and expertise.
• Excellent federal government benefits package (health insurance, life insurance, retirement, etc.).
• Student loan repayment may be paid to eligible candidates.
• Flexible and telework-eligible schedules available (requires 2-days onsite in Silver Spring, MD and 8-days telecommute each 2 weeks’ pay period).

QUALIFICATIONS

Applicants must have a graduate/higher level degree in a behavioral or social science, or related disciplines appropriate to 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. The candidate will interact extensively with others within FDA, academia, and industry and should have excellent written and oral communication skills.

TO APPLY

Please send a current CV/resume and cover letter to ond-employment@fda.hhs.gov for consideration. Please reference source code: #24-036EG in the subject line.