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Senior Manager, Regulatory Program Operations

| Greater NYC Area

Flatiron Health is looking for a Senior Manager of Regulatory Program Operations to join our growing Regulatory Policy team. This team is responsible for driving forward our growing body of work with our regulatory partners, which is increasingly strategically critical to truly moving the needle on Flatiron’s mission.

The responsibilities of this role will include overseeing the execution of projects done in collaboration with regulatory bodies, as well as serving as a cross-functional bridge internally at Flatiron across the project teams executing the work. This job requires an analytical mind, client management and organizational skills, and excitement to build something from the ground up. A successful candidate will get to take part in a collaborative, high-profile, multi-stakeholder team focused on shaping novel use cases for real-world data and other Flatiron solutions, helping to tackle one of the most complex medical and technological challenges of our time.

Responsibilities:

  • Support Director, Regulatory Policy in researching, crafting, and disseminating Flatiron’s Real-World Evidence Policy positioning (e.g., white papers, Comments)
  • Drive internal collaboration with cross-functional project teams, including Research Oncology, Quantitative Sciences, and Operations, while maintaining end-to-end timelines and project plans
  • Play life sciences relationship management role with FDA, NCI, FOCR and others
  • Serve as Flatiron’s primary regulatory agency liaison for new regulatory-focused projects and cross-functional initiatives
  • Lead problem-solving discussions with internal and external stakeholders (e.g., Life Sciences Partnerships, Research Oncology, Clinical Data Abstraction, Product, Engineering, and Quantitative Sciences) to ensure that all necessary inputs are considered and the team collectively makes clinically and scientifically sound decisions
  • Lead or support meetings and engagements with external stakeholders (e.g., Life Sciences companies and Academic Research Centers)
  • Track and communicate progress and decisions clearly and regularly to internal and external stakeholders
  • Triage issues to the appropriate internal stakeholder and ensure timely effective issue resolution
  • Collaborate and reliably share feedback from regulatory bodies and clients with Flatiron’s team of product managers, engineers, business development leaders, and other cross-functional colleagues
  • Own Flatiron’s preparation for and participation at relevant regulatory-focused conferences and workshops (e.g., slide creation, speaker prep, attendee management, transmission of learnings post-event)
  • Stay up to date on official FDA communications for relevance to Flatiron’s RWE business

Requirements:

  • Bachelor’s degree or equivalent experience
  • Spike in project management and communication skills
  • Experience working on cross-functional teams
  • Experience with or deep understanding of scientific methodologies or statistics
  • Work experience in one of the following types of highly structured or scientific environments: academic hospital, management/healthcare consulting, research foundation, or CRO/ARO
  • The ability to juggle multiple client interactions and deadlines simultaneously and the versatility to collaborate with individuals at all levels and across various functions within regulatory and life sciences firms
  • Passion to fight cancer
  • Open to semi-frequent travel (1-2 times per month) to DC

Bonus Points:

  • Health policy knowledge
  • Experience managing a small team
  • Background as government affairs professional in health sector
  • Experience in epidemiological or outcomes research (real-world evidence)
  • Advanced degree: MBA, MPH, MS, PhD


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Technology we use

  • Engineering
    • .NETLanguages
    • C#Languages
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • jQueryLibraries
    • ReactLibraries
    • AngularJSFrameworks
    • ASP.NETFrameworks
    • Node.jsFrameworks
    • Microsoft SQL ServerDatabases
    • PostgreSQLDatabases

Location

Our office at One Soho is easily accessible and modern, and has all the amenities our employees need to be comfortable, productive and collaborative.

An Insider's view of Flatiron Health

What’s the vibe like in the office?

The most exciting part of being in my company is solving a real problem at scale through serious collaboration. Oncologists, software engineers, statisticians, business folks, etc. all have to come to the table together, as equals, to figure this one out. And we are doing it.

Amy

Chief Medical Officer

What kinds of technical challenges do you and your team face?

An engineer and oncologist work together over several weeks to build an algorithm from a naive prototype to a highly specialized and flexible rule set that can accurately represent the lines of therapy for 95% of patients within a specific disease subset.

Abhishek

Software Engineer

How does the company support your career growth?

As engineering manager, I am invested in the professional development of the people I work with. I train team members by pulling them out of their comfort zones to the uncomfortable territory. At Flatiron, it is one of our values - greatness and comfort rarely co-exist.

Kevin

Software Engineer

What is your vision for the company?

At Flatiron, we believe that learning from the experience of every cancer patient is an imperative — it is the key to accelerating research and continuing to improve the quality of care. Our mission is to serve cancer patients and our customers by dramatically improving treatment and accelerating research.

Zach Weinberg

Co-Founder, President and COO

What's the biggest problem your team is solving?

Instead of studying the cells, I now have the opportunity to write about the patients. I can tell their stories through the research lens and enable them to advance clinical cancer research through their experiences. I certainly never lose sight of the human behind the cell anymore.

Rana

Medical Writer

What are Flatiron Health Perks + Benefits

Flatiron Health Benefits Overview

Flatiron has a holistic approach to employee experience. We promote a culture with wellness at the forefront.

Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Family Medical Leave
Vacation & Time Off Benefits
Generous PTO
Paid Volunteer Time
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Stocked Kitchen
Happy Hours
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
Diversity Program
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