The Reagan-Udall Foundation for the FDA (the FDA Foundation) is a nonprofit organization that works to support the mission of the FDA by advancing regulatory science and research. The FDA Foundation establishes public-private partnerships between FDA and external stakeholders to facilitate innovation in science and health. We value diversity in our team and believe an inclusive workplace yields more meaningful outcomes.

Project Title: Landscape Analysis of the Use of Real-World Data for Post-Market Studies in Pregnant and Lactating Persons

Position Description:

Currently, patient registries, both disease and product-specific, are considered the gold standard for assessing post-market drug safety and effectiveness in pregnant and lactating persons. However, there are many challenges to using patient registries for this purpose, including low rates of enrollment, low rates of retention, high rates of missing data, difficulties linking data, and difficulties identifying an appropriate comparator group. Some experts have suggested that patient registries may not be the best tool for assessing post-market drug safety and effectiveness studies in pregnant and lactating persons. The FDA Foundation is looking for an intern to assist in gathering and reviewing evidence leveraging real- world data to assess post-market drug safety and effectiveness studies in pregnancy and lactating persons through structured interviews and roundtable discussions among experts. This information will be used in the development of medical products suitable for pregnant and lactating women.

Dates: May/June 2022 – August/September 2022; option to extend through December 2022

Hours: Flexible; 20 hrs/week; option to work either remotely or in our DC office

Gain Experience in:

  • Preparing a robust literature scan, including developing a list of search terms, identifying relevant articles and resources, building a warehouse of the literature, and summarizing key themes
  • Identifying relevant experts from companies and organizations who are engaged in the design, recruitment, and conduct of post-market drug safety and effectiveness studies in pregnant and lactating persons
  • Contributing to the drafting process for interview questions and a discussion guide
  • Supporting the development and production of interviews with experts, including regulators, researchers, health systems, clinicians, payers, and patient organizations
  • Preparing written content and tables/figures to summarize findings from the project

Qualifications:

  • Currently pursuing a graduate degree (masters or doctoral) in informatics, pharmacoepidemiology, epidemiology, health economics, public health, or other health-related area of study
  • Familiarity with best practices in the conduct of research (e.g., CONSORT guidelines, human subjects)
  • Highly detail-oriented and deadline-driven, with superior organizational skills
  • Highly motivated to work independently/remotely, as well as in team settings
  • Must be reliable, creative, flexible, and self-motivated
  • Ability to keep sensitive information confidential

Desired Skills, Competencies and Interests:

  • Past experience conducting public health research
  • Interest in addressing health equity and racial/ethnic disparities in health
  • Proficiency with MS Office (Word, Excel, Access, PowerPoint and Outlook) and relevant web- based applications (e.g., Eventbrite, MailChimp, SurveyMonkey, Doodle)

How to apply:

To apply for this position, please submit a resume and cover letter to careers@reaganudall.org. If you require accommodation in the interview process or to perform your job, please do not hesitate to let us know in advance.

Compensation:

$20-25/hour, depending on qualifications and experience.