Manager, Regulatory Policy [FDA-focused] at Flatiron Health
[Please note that this is an office based position at Flatiron's office in New York, NY]
We're looking for a Manager, Regulatory Policy [FDA focused] to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here's what you need to know about the role, our team and why Flatiron Health is the right next step in your career.
What You'll Do
In this role, you'll work with the Regulatory Policy team to facilitate strategic engagement with the Food and Drug Administration (FDA), other medical product regulators, and related stakeholders. In order to support regulatory policy engagement, Flatiron Health strives to understand and interpret the policy landscape, develop our own policy positions, and work with stakeholders to shape external policies with respect to the use of real-world data. The Regulatory Policy team is particularly focused on policies related to the use of real-world data to support regulatory decision making about drugs, biologics and/or medical devices.
Reporting to the Senior Director, Regulatory Policy, you'll support Flatiron’s portfolio of policy work, including research demonstration projects. You will help execute Flatiron’s regulatory policy roadmap by: preparing policy analyses, conducting regulatory policy intelligence/surveillance, stakeholder relationship development, policy meeting management, and communications. You'll act as bridge between cross-functional Flatiron Health staff in different locations (e.g., New York and Washington DC). In addition, you'll also:
- 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 the Food and Drug Administration’s (FDA) (and other global regulators) use of real-world evidence, including summaries of regulatory guidance, regulations, medical product decision review documents, and publications from policy/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
- Coordinate internally to scope, execute, and deliver results of research projects in support of policy (e.g., conference posters, peer-reviewed manuscripts)
- 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)
In this role, you’ll have the opportunity to 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, Research Oncology, Quantitative Sciences, Marketing, and Engineering.
Who You Are
You're a candidate with 5 or more years of direct regulatory policy experience. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You’re a kind, passionate and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.
- You have direct policy experience with a highly regulated sector of healthcare (e.g., life science company, government agency)
- You have familiarity with FDA’s Center for Drug Evaluation and Research (CDER) and/or Center for Biologics Evaluation and Research (CBER) and guidance and regulations pertaining to medical products
- You are an excellent communication skills (both oral and written), including communicating in a variety of formats at all levels and across various disciplines
- You have experience managing complex projects that are scientific, technical, analytical, and/or regulatory in nature.
- You are able to work within cross-functional teams and manage multiple simultaneous projects
- You are passionate about Flatiron’s mission to improve lives by learning from the experience of every cancer patient
- You are able to travel to Washington, DC as needed (approximately 1-2 times per month)
- You have a bachelor’s degree or equivalent experience
If this sounds like you, you'll fit right in at Flatiron.
- You have direct experience working with domestic government health organizations such as HHS, NCI, or international health authorities and regulatory bodies such as European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.
- You have direct experience with medical product development, regulatory affairs, or regulatory policy (primarily FDA-focused work)
- You have broad knowledge regarding key policy issues in healthcare, such as coverage/reimbursement or delivery
- You have experience interpreting and translating complex regulatory requirements
- You have experience in clinical research, epidemiological, or outcomes research (real-world evidence)
- You have a familiarity with oncology
- You have direct experience with scientific and/or regulatory writing
- You have an advanced degree: MBA, JD, RN, MPH, MS, PhD, MPA, PharmD
Why You Should Join Our Team
A career at Flatiron is a chance to work with everyone involved in the future of cancer care and research—all under one roof. Researchers, data scientists, designers, clinicians, technologists and many more all work together to improve cancer care and accelerate research.
You'll also find a culture of continuous learning, broad and inclusive employee support offerings, and a commitment to supporting our team members in all aspects of their lives—at home, at work and everywhere in between. We offer:
- Flatiron University training curriculum which includes presentation skills, meeting mastery, coding languages and more
- Career coaching opportunities
- Hackathons for all employees (not just our engineers!)
- Professional development benefit for attending conferences, industry events and external courses
- Work/life autonomy via flexible work hours and flexible paid time off
- Generous parental leave (16 weeks for either parent)
- Back-up child care
- Flatiron-sponsored fitness classes
Flatiron Health is proud to be an Equal Employment Opportunity employer.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.