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[Open Level] Research Quality and Compliance, Computer Systems Validation (CSV)

| 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 simultaneous federal and state regulations coupled with defined requirements from the US Food and Drug Administration, Health and Human Services, Center for Medicare and Medicaid Services, and others.

To that end, our Research Quality & Compliance team is seeking experienced computer systems validation (CSV) professionals to define and drive Flatiron’s strategy with regard to adherence to applicable regulatory requirements (e.g. 21 CFR Part 11: Electronic Records; Electronic Signature). These positions will support Flatiron’s research initiatives in their efforts to deliver high quality data and and to ensure compliance. Such support includes collaborating with key internal and external stakeholders to provide guidance on technical compliance matters and lead the implementation of key elements of the quality and compliance program against strategic priorities.

We are looking for validation professionals at various levels as follows:

Coordinator: Applicants with direct experience with completion of day to day validation activities. Looking for at least 2 years of direct experience.

Lead: Applicants with direct experience with completion of day to day validation activities. Looking for at least 4 years of direct experience.

Manager: Applicants with direct experience with oversight and strategy of validation activities. Direct experience with creating/managing a validation program. Looking for at least 6 years of direct experience.

Responsibilities:

  • Provide proactive compliance support regarding best practices, document control, process development/improvement and risk management for computer systems. Enhance and implement Flatiron’s quality system to ensure compliance with applicable regulatory requirements. Assess internal compliance with Flatiron’s quality system.
  • Determine the appropriate level of qualification and validation necessary for electronic systems to ensure compliance with relevant regulations and industry guidance documents. Design, implement and oversee risk-based computer systems validation activities (e.g. specifications, testing, qualification, release). Guide and reconcile any associated corrective and preventive actions needed to ensure compliance.
  • Provide hands-on support to ensure the completion of computer system validation and the associated documentation (e.g. plans, protocols, reports, memos).
  • Foster a quality culture focused on meeting high quality, ethical and compliance standards.
  • Enhance and implement document control and training plans for a compliant approach to the software development lifecycle (SDLC).
  • Design, implement and oversee compliance training.
  • Ensure proactive audits/inspection readiness. Oversee 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, complete, document and closure audits of Flatiron vendors.
  • Collaborate with our Product Management, Quantitative Science, Abstraction, Oncology, Security and Software Engineering teams to advise on the correct application of internal and external regulations for computer systems projects.

Requirements:

  • Experience of working within a highly regulated environment (e.g. licensed laboratory, commercial manufacturing, life sciences)
  • Bachelor’s degree required
  • 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 for computer systems validation
  • Strong working knowledge of regulations for electronic systems validation (specifically 21 CFR Part 11)
  • Experience in developing an organizational “culture of compliance” and risk-based validation activities
  • Experience drafting, reviewing, implementing and ensuring compliance with research procedures that drive efficiency and foster a creative approach to solving business needs
  • Ability to work within cross-functional team and manage multiple simultaneous projects
  • Structured communication skills
  • Passionate about our mission to improve healthcare through technology

Ideal Experience:

  • Direct experience as a computer systems validation auditor (e.g. internal audits, vendor audits).
  • Experience with agile software development (ideally agile software development)

Bonus Points:

  • Familiarity with regulations and the associated guidance documents relevant to clinical trials (e.g. 21 CFR parts 50, 312, 314, 812, 814) or Good Clinical Practice (GCP)
  • Understanding of the global regulatory landscape (e.g. European regulations such as annex 11) and ability to apply global best practices to daily tasks
  • Oncology and/or 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.
  • You’ve worked at a technology partner to a life sciences company
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 has returned to Soho. We're right next to Trader Joe's! Soho is filled with boutiques, fancy chain stores and art galleries.
One Soho Square at 233 Spring Stree, New York, NY 10013

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 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

Flatiron Health Benefits Overview

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.

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
Daily catered meals
Stocked Kitchen
Endless snacks & beverages
Happy Hours
Professional Development Benefits
Job Training & Conferences
Robust learning & development curriculum. Participate at industry events.

Additional Perks + Benefits

On a monthly basis, we host a Wellness Day that includes massages, manicures, and meditation sessions. We often set up booths for local wellness organizations and fund on site and off site fitness classes. We also host a bi-weekly meditation in the office.

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