for Consulting Professionals
FDA Regulatory and Policy Consulting Professional
Our sector-leading FDA regulatory and policy consulting team at Faegre Drinker is seeking a new colleague with 5-10 years of experience in the field and a passion for the patient-focused drug development arena. We serve patient advocacy organizations, research institutions, and industry as they collaborate to develop new therapies and bring them to market. Our practice is well-recognized for supporting several landmark client initiatives in the field including patient community-led drug development guidances, patient experience data platforms, and innovative clinical trial strategies. Our engagements span the pipeline from innovation in the lab through the market access stage.
Ideal candidates will have experience in the FDA regulatory process and appreciation for the policymaking interface. They will have demonstrated the ability to help produce tangible results in FDA regulatory matters in roles with industry, non-profit organizations, Congress, and/or the FDA. They also will understand the biomedical research and public health domains. They will appreciate healthcare policy more broadly and be able and willing to work on clients issues extending beyond FDA. The successful candidate will be expected to manage or co-manage multiple projects, prepare analysis and presentation materials, support development of survey instruments and related tools, and manage meetings of various sizes. The successful candidate may also engage on public policy issues pertaining to the topics, including supporting legislative or regulatory advocacy that may require registration under the Lobbying Disclosure Act.
Candidates should possess:
- Superior written and oral communications abilities, including the ability to deliver information to both internal and external recipients and to persuade recipients to accept a point of view;
- A strong understanding of the FDA regulatory process, including an understanding of relevant regulatory science and related issues;
- Ability to think critically including the ability to anticipate and address potential challenges or impediments;
- Ability to understand and synthesize complex regulatory and policy issues;
- Ability to manage multiple client priorities concurrently;
- Demonstrated willingness to work hard, do what it takes, and drive toward results; and
- A track record of working effectively in teams while being able to operate independently to execute deliverables.
Integrity, commitment to teamwork, organizational skills, a sense of urgency, and a passion for life sciences and health innovation are required. Our firm offers a creative, collegial, and high-energy environment, as well as a dedicated consulting professional career pathway and a commitment to diversity, equity, and inclusion.