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.
The Research Associate (RA) will manage and provide leadership for activities associated with the development and conduct of research partnerships in public health. The RA will manage a variety of projects conducted and funded by external research partners. The RA will routinely collaborate with leading experts from government agencies (primarily the U.S. Food and Drug Administration (FDA), industry, non-profit organizations, and academia to support the design, promotion, funding and monitoring of research studies and projects related to regulatory science, pharmaco-epidemiology, use of real-world data, and/or public health knowledge, attitudes, and behaviors. The research portfolio includes large scale collaborative observational 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.
Specific activities could include collaborating with senior staff to oversee and manage multiple projects related to regulatory science. The RA will be expected to manage all aspects of specific projects including developing project budgets and timelines, coordinating communication and activities across all project team members and stakeholders, monitoring the status of deliverables, and successfully negotiating the timely resolution of conflicts as they arise. Specific research activities may include: 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 and data tables. The RA may be asked to mentor junior staff, overseeing the preparation of meeting materials including meeting agendas, pre-read packets, and slide decks, and meeting summaries.
The RA will report to the Director of Research. Minimal travel may be required for this position. Occasional work on weekends and nights may be required.
The RA should be intellectually flexible and comfortable working with funding and research partners in technical areas they do not consider to be their primary area of expertise.
Required characteristics for the RA position include:
- Master’s degree
- Excellent writing skills and critical thinking skills
- Three years full-time research experience
- Excellent organizational and project management skills with keen attention to detail
- Ability to manage multiple ongoing projects and collaborate on cross-team activities
- Creative self-starter
- Problem solver
- Intellectually curious
- An 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).
Work Location: Work from home options available
Tour of Duty: Full-time
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Vision insurance
We follow CDC recommendations.
Key words: Research associate; pharmacoepidemiology; regulatory science; public health; real-world data; research methods; project management
To apply: Email your cover letter, resume, two references and your salary requirements to email@example.com. If you require accommodation in the interview process or to perform your job, please do not hesitate to let us know in advance.