Senior Research Associate Jobs

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 Senior Research Associate (SRA) with an interest in joining a small and growing team and a willingness to stretch and take on additional responsibilities as needed.

Job description:

The SRA will manage and provide leadership for activities associated with the development and conduct of research partnerships in public health. The SRA will manage a variety of research projects conducted and funded by external funding partners. The SRA 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 pharmaco-epidemiology, use of real-world data, and/or public health knowledge, attitudes and behaviors. The research portfolio at the Foundation includes a wide variety of public health research activities, such as large-scale, collaborative, observational and/or clinical trials, regulatory science projects to advance the use of high-quality real-world data and other novel study approaches, as well as studies designed to develop and meet regulatory requirements for post-market surveillance of regulated products.

Specific activities could include collaborating with senior staff and outside consultants to oversee and manage multiple projects related to regulatory science. The SRA will be expected to manage all aspects of specific projects including developing project budgets and timelines, 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; and preparing reports and data tables. The SRA will be expected to mentor junior staff and oversee the preparation of meeting materials including meeting agendas, pre-read packets, and slide decks, and meeting summaries.

The SRA will report to the Director of Research. Minimal travel may be required for this position. Occasional work on weekends and nights may be required.

Job qualifications:

The SRA 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

·Five years research experience

·Superior organizational and project/program management skills

·Ability to multi-task

·Team player

·Attention to detail

·Creative self-starter

·Problem solver

·Intellectually curious

Preferred characteristics:

·Background or experience in public health pharmacoepidemiology, outcomes research, and/or observational data methods.

·Familiarity with FDA process and/or regulations for post-authorization studies (primarily) and drug or biological product development (secondary).

·Experience mentoring junior staff