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 accomplishes this role by establishing 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 for the Foundation, the FDA, and stakeholders.

The Foundation is seeking a mission-driven Research Associate (RA) with an interest in joining a small and growing team and a willingness to stretch and take on additional tasks as needed.

Description:

This is an exciting opportunity for someone who is interested in continuous learning and in being in the same room as experts in public health, regulatory science, pharmacoepidemiology, life sciences, outcomes research, and the industries that support this work.

The RA will work on projects associated with the development and conduct of research partnerships and convenings in public health. The RA will support a variety of externally funded projects. The RA will routinely engage with leading experts from government agencies (primarily the FDA), industry, non‐profit organizations, and academia to support the design, promotion, funding and monitoring of research studies and projects. The RA will support research projects and convenings that address topics related to regulatory science, pharmaco-epidemiology, use of real-world data, and/or public health knowledge, attitudes, and behaviors. The RA will support the Innovation in Medical Evidence and Development Surveillance (IMEDS) program which can be used to conduct large scale collaborative observational studies and/or clinical trials, along with studies designed to develop and meet regulatory requirements for post-market surveillance of regulated products. The RA should be detail‐oriented, organized, adept at managing multiple assignments, and comfortable in a fast-paced environment.

The day-to-day tasks of the RA may include supporting the development of project budgets and timelines; coordinating communication and activities across all project team members and stakeholders; monitoring the status of deliverables; conducting literature reviews and data abstraction; summarizing data from multiple partners; developing surveys, interview guides, and focus group moderation guides; preparing meeting agendas and materials; meeting scheduling; preparing reports, data tables, slide decks, and meeting summaries.

The RA will report to the Research Manager. Minimal travel may be required for this position. Occasional work on weekends and nights may be required to prepare for events and deadlines. Such events are rare and may include attending meetings, conferences, and/or FDA Foundation events. On balance, the Foundation accommodates flexible work schedules and hybrid work from office or home arrangements.

Qualifications:

The RA should be intellectually flexible and comfortable working with funding and research partners in technical areas they may not consider to be their primary area of expertise. The successful candidate will have an interest in continuous learning; comfortable with collaboration with team members, particularly in a hybrid remote/in-person environment; an appreciation for the iterative learning process; and will bring their superior organization, collaboration, and self-starter skills to this job.

Required skills for the RA position include:

  • Excellent writing and critical thinking skills
  • Excellent organizational and project management skills with keen attention to detail. At least 1 year of project management experience.
  • Provide basic project management support, including preparation of meeting materials and background information, note taking, efficient, courteous meeting scheduling across external and internal stakeholders
  • Juggle project work with multiple managers, across various teams
  • Ability to work on multiple projects (3-4) and collaborate on developing work products with team members under the supervision of a program coordinator or project manager
  • Creative self-starter, but also a collaborative team-player
  • Problem solver
  • An interest in life-long learning and intellectually curious
  • Experience working with Microsoft Office suite: power point, excel, word.

Preferred characteristics:

  • A basic understanding of public health, regulatory science, pharmacoepidemiology, outcomes research, and/or observational data methods (clinical/epidemiological research background preferred).
  • Familiarity with FDA process and/or regulations for post-authorization studies (primarily) and drug or biological product development (secondarily).
  • Three years of project management experience, including use of project management software.
  • Master’s Degree in relevant field.

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Professional development assistance
  • Vision insurance

Salary:

  • $55,000 - $90,000 Commensurate with experience

Schedule:

  • Monday to Friday

COVID-19 considerations:

  • We follow CDC recommendations.

Work location: Dupont Circle, Washington, DC. Hybrid schedule with remote options available.

To apply: Email your cover letter, resume, three references and your salary requirements to careers@reaganudall.org.

Key words: Research associate; pharmacoepidemiology; regulatory science; public health; real-world data; research methods; project management