Integrated Quality Management [Open Level]

| Greater NYC Area

[Please note that this is an office based position at Flatiron's office in New York, NY]

Flatiron Health expects our organization to meet high quality, ethical and compliance standards. We operate in a highly regulated space, with defined requirements from the US Food and Drug Administration (FDA), Health and Human Services (HHS), Center for Medicare and Medicaid Services (CMS), and others.

To that end, Flatiron Health’s Integrated Quality Management (IQM) team is seeking experienced quality assurance (QA) professionals to define, maintain, and oversee the quality system. These positions will provide quality partnership across Flatiron Health’s business through quality management and quality oversight activities intended to accelerate quality improvement. This includes support for our community oncology (e.g., electronic health records [EHRs], insurance billing), research (e.g., human subjects protection), and/or academic medical centers (e.g., scientific publications) initiatives. Such support includes collaborating with key stakeholders to provide guidance on compliance matters and lead the implementation of key elements of the quality and compliance program against strategic priorities.

We are looking for professionals at various levels as follows:

Coordinator: Applicants with experience with completion of day to day research activities (e.g. data review, project tracking). Looking for at least 2 years of experience in healthcare, technology or a quality related field.

Lead: Applicants with direct experience with completion of day to day compliance activities (e.g. document control, training plans, project support). Looking for at least 4 years of direct experience in healthcare, technology or a quality related field.

Manager: Applicants with direct experience with oversight and strategy of compliance activities. Direct experience with thinking about how to create a compliance program. Looking for at least 6 years of direct experience in healthcare, technology or a quality related field.

Responsibilities (involvement will vary based on level):

  • Provide proactive compliance support regarding research best practices, document control, process development/improvement and risk management. Enhance and implement Flatiron’s quality system to ensure compliance with applicable regulatory requirements. Assess internal compliance with Flatiron’s quality system.
  • Implement risk-based quality management activities focused on risk assessment, identification, escalation and management. Guide and reconcile any associated corrective and preventive action plans.
  • Foster a quality culture focused on meeting high quality, ethical and compliance standards.
  • Enhance and implement document control and training plans for research procedures.
  • Design, implement and oversee compliance training.
  • Ensure proactive audits/inspection readiness. Oversee all external audits/inspections of Flatiron’s data and research businesses, including liaising with clients, hosting on-site visits, and internal oversight of associated action plans. Plan, facilitate, document and closure audits of Flatiron vendors.
  • Collaborate with internal teams to draft, review and maintain procedures.

Requirements:

  • Direct experience within a highly regulated environment (e.g. life science company, contract research organization [CRO], etc.) within healthcare, technology and/or research
  • Working knowledge of US FDA drug and/or biologic regulations. Familiarity with regulations and the associated guidance documents relevant to clinical trials (e.g. 21 CFR parts 50, 312, 812) and electronic data (e.g. 21 CFR Part 11).
  • Proactive compliance support methodology that can translate complex regulatory principles into best practices for cross-functional research teams
  • A flexible approach to compliance; ability to translate and infuse compliance knowledge and best practices into research deliverables
  • Bachelor’s degree required
  • Ability to work within cross-functional team and manage multiple simultaneous projects
  • Structured communication skills
  • Passionate about our mission to improve healthcare through technology

Bonus Points:

  • Experience in developing an organizational “culture of compliance” and defining a quality system
  • Experience drafting, reviewing, implementing and ensuring compliance with research procedures (SOPs) that drive efficiency and foster a creative approach to solving business needs
  • Clinical trials and/or clinical research experience, such as oversight of multi-center clinical research activities including participant screening and recruitment, oversight of clinical research organization and/or vendors supporting research
  • Experience conducting clinical trials at a clinical research site and/or experience as a study coordinator, monitor (i.e. Clinical Research Associate), project manager
  • Understanding of the global regulatory landscape (e.g. European regulations) and ability to apply global best practices to daily tasks
  • Oncology experience
  • Clinical experience (e.g. nursing degree)
  • Scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
  • Experience with designing protocols, case report forms, regulatory submissions, etc.
  • Experience with late-phase research such as phase 3B/4 trials
  • Experience with health outcomes and economic research
  • Experience with systems development life cycle (SDLC) and validation compliance
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

Flatiron Health is in the heart of the Flatiron District. Eataly is right downstairs and we oversee Madison Square Park.
200 5th Avenue, New York, NY 10010

Insider's spotlight

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 Engineering

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

Health Insurance & Wellness Benefits
Dental Benefits
Vision Benefits
Health Insurance Benefits
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Paid Volunteer Time
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Stocked Kitchen
Happy Hours
Professional Development Benefits
Job Training & Conferences

Additional Perks + Benefits

Flatiron’s holistic employee experience program translates our values into reality.
We cater to the well being of our employees both mentally and physically to promote a culture where wellness is at the forefront. By managing weekly mental wellness programs, monthly office wide fun and fitness classes, we give employees the opportunity to directly incorporate a mindful balance into their day to day life.

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