Program Manager, Regulatory Policy
[Please note that this is an office based position at Flatiron's office in New York, NY]
Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care. Our platform enables cancer researchers and healthcare providers to learn from the experiences of every patient. In order to advance this mission, Flatiron Health’s Regulatory Policy team facilitates strategic engagement with the Food and Drug Administration (FDA) and other government agencies, industry groups, patient advocates, scientific thought leaders, academia, and life science partners.
In order to support regulatory policy engagement, Flatiron Health works with policy stakeholders to understand and interpret the external policy environment, develop Flatiron’s policy positions, and work to shape external policies with respect to the use of real-world data. Part of this work involves the design, review, implementation, delivery, and publishing of demonstration projects leveraging real-world data. To that end, Flatiron Health is seeking an experienced program management to assist in policy analysis, development and program management of research in support of policy, including demonstration projects with collaborators. In addition to supporting demonstration projects, this position will help execute Flatiron’s regulatory policy roadmap by: preparing policy analyses, conducting regulatory intelligence/ surveillance, stakeholder relationship development, policy meeting management, and communications. This role will act as a cross-functional bridge between Flatiron Health staff across locations (e.g., New York and Washington DC).
- Help monitor, analyze, and anticipate changes in the regulatory landscape and contribute to impact analyses of emerging regulatory policies on Flatiron’s business and policy goals
- Produce policy analyses related to FDA’s (and other global regulators) use of real-world evidence, including summaries of regulatory guidance, regulations, medical product decision review documents, and publications from advocacy organizations
- Prepare and coordinate internal stakeholder feedback on proposed laws, regulations and guidances, to ensure communication of Flatiron positions
- Communicate policy analyses with internal and external stakeholders through written materials and coordination of internal education programs
- Project manage multiple, concurrent research projects in support of regulatory policy development through collaboration with cross-functional teams from different disciplines including (but not limited to) Product Management, Operations, Oncology, Quantitative Sciences, Marketing, and Engineering
- Coordinate internally to scope, execute, and deliver results of research projects in support of policy, often with final deliverable being a publication (e.g., conference poster, peer-reviewed manuscript)
- Help facilitate communication between internal teams and external stakeholders
- Work with the Regulatory Policy Director and Senior Director to define, implement, and enhance Flatiron’s regulatory policy roadmap and strategic priorities
- Help research, draft, review, and disseminate materials to support the regulatory policy roadmap (e.g., white papers, comments for proposed regulations)
- Work with the Regulatory Policy team to ensure successful participation in relevant regulatory-focused conferences and workshops (e.g., slide creation, speaker preparation, attendee management, transmission of learnings post-event)
- Direct policy experience with a highly regulated sector of healthcare (e.g., life science company, government agency)
- Familiarity with one or more of the following United States regulatory organizations: FDA, Health & Human Services (HHS), Centers for Medicare and Medicaid Services (CMS)
- Excellent communication skills (both oral and written), including communicating in a variety of formats at all levels and across various disciplines
- Experience managing complex projects that are scientific, technical, analytical, and/or regulatory in nature.
- Ability to work within cross-functional teams and manage multiple simultaneous projects
- Passionate about Flatiron’s mission to improve lives by learning from the experience of every cancer patient
- Ability to travel to Washington, DC (approximately 1-2 times per month)
- Bachelor’s degree or equivalent experience
- Direct experience working with domestic government health organizations such as FDA, HHS, NCI, or comparable international health agencies such as European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.
- Familiarity with the regulatory affairs or regulatory policy (primarily FDA)
- Broad health policy knowledge
- Background as a policy or government affairs professional in health sector
- Experience interpreting and translating complex regulatory requirements
- Experience in clinical research, epidemiological, or outcomes research (real-world evidence)
- Oncology experience
- Direct experience with scientific and/or regulatory writing
- Advanced degree: MBA, MPH, MS, PhD, PharmD