Oh Snap!
This job is no longer active - but you can still view the details below.

Program Manager, Regulatory Policy

| Greater NYC Area

[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 government agencies, industry groups, patient advocates, scientific thought leaders, academia, life science partners, etc.

In order to support regulatory policy engagement, Flatiron Health works with policy stakeholders to design, review, implement, deliver, and publish demonstration projects leveraging real-world data. To that end, Flatiron Health is seeking an experienced Program Manager to oversee these demonstration projects and support the broader regulatory policy roadmap. This position will be accountable for program management throughout the lifecycle of demonstration projects, including but not limited to coordinating cross-functional internal project teams, facilitating communication with external stakeholders, timeline management, issue management, etc. In addition to supporting demonstration projects, this position will provide flexible support across the regulatory policy roadmap (e.g., regulatory intelligence/ surveillance, stakeholder relationship development, policy meeting management, policy communications). This role will act as a the cross-functional bridge between Flatiron Health staff in New York and policy stakeholders outside of New York (e.g., Washington DC).

Responsibilities:

  • Provide proactive project management oversight for multiple concurrent demonstration projects intended to support the regulatory policy roadmap in collaboration with cross-functional internal teams comprised of different disciplines including but not limited to Product Management, Operations, Oncology, Quantitative Sciences, Marketing, and Engineering teams
  • Scope, execute, and deliver end-to-end projects, often with final deliverable being a publication (e.g., conference poster, peer-reviewed manuscript)
  • Proactively manage timeline, operational, and/or technical issues to ensure timely and robust project delivery
  • Track and communicate progress and decisions clearly and regularly to internal and external stakeholders
  • Facilitate communication between internal teams and senior external stakeholders at Food and Drug Administration (FDA), National Cancer Institute (NCI), and other regulatory partners for demonstration projects
  • Enhance ongoing and future program management activities across the regulatory policy roadmap based on project management competencies to ensure continuous improvement
  • Work with the Regulatory Policy team to liaise with external policy stakeholders including but not limited to government agencies, industry groups, patient advocates, scientific thought leaders, academia, and life science partners
  • Work with the Regulatory Policy team to define, implement, and enhance the regulatory policy roadmap
  • Work with the Regulatory Policy team to 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 prep, attendee management, transmission of learnings post-event)

Requirements:

  • Direct experience managing complex projects that are scientific, technical, analytical, and/or regulatory in nature. Looking for at least 6 years of direct program management experience
  • Ability to work within cross-functional teams and manage multiple simultaneous projects
  • Direct experience within a highly regulated environment such as healthcare (e.g., hospital, health insurance company, government agency, life science company)
  • Familiarity with one or more of the following United States (US) regulatory frameworks: FDA, Health & Human Services (HHS), Office of National Coordination of Health IT (ONC), Centers for Medicare and Medicaid Services (CMS)
  • Experience with analytical and quantitative problem solving
  • Structured communication skills (both oral and written) at all levels and across various disciplines
  • Passionate about our 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

Bonus Points:

  • Direct experience working with domestic government health agencies 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)
  • Health policy knowledge
  • Background as government affairs or policy professional in health sector
  • Experience interpreting and translating complex regulatory requirements
  • Experience in clinical research, epidemiological, or outcomes research (real-world evidence)
  • Oncology experience
  • Clinical experience (e.g., nursing or pharmacy)
  • Experience working with oncologists/clinicians
  • Direct experience with scientific and/or regulatory writing
  • Advanced degree: MBA, MPH, MS, PhD
Read Full Job Description

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 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.

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Intracompany committees
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Unconscious bias training
Diversity manifesto
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
More Jobs at Flatiron Health81 open jobs
All Jobs
Finance
Data + Analytics
Design + UX
Dev + Engineer
HR
Legal
Marketing
Operations
Product
Project Mgmt
Sales
Operations
new
New York
Data + Analytics
new
New York
Marketing
new
New York
Developer
new
New York
Data + Analytics
new
New York
Developer
new
New York
Data + Analytics
new
New York
Developer
new
New York
Data + Analytics
new
New York
Operations
new
New York
Project Mgmt
new
New York
Data + Analytics
new
New York
Design + UX
new
New York
Operations
new
New York
Design + UX
new
New York
Data + Analytics
new
New York
Finance
new
New York
Project Mgmt
new
New York
Developer
new
New York
Project Mgmt
new
New York
Operations
new
New York
Operations
new
New York
Project Mgmt
new
New York
Developer
new
New York
Developer
new
New York
Developer
new
New York
Data + Analytics
new
New York
HR
new
New York
Project Mgmt
new
New York
Operations
new
New York
Data + Analytics
new
New York
Operations
new
New York
Data + Analytics
new
New York
Data + Analytics
new
New York
Sales
new
New York
Data + Analytics
new
New York
Developer
new
New York
Data + Analytics
new
New York
Developer
new
New York
Finance
new
New York
Developer
new
New York
Data + Analytics
new
New York
Data + Analytics
new
New York
Operations
new
New York
Developer
new
New York