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About the Role
Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem. We’re looking for a Regulatory and Legal Operations Manager to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer.
Responsibilities
- Develop and execute against the regulatory program roadmap to ensure regulatory requirements are timely and effectively implemented
- Serve as primary liaison between legal and business and technical stakeholders to translate regulatory requirements into actionable plans
- Drive accountability with teams to ensure timely completion of regulatory requirements
- Compile and submit regulatory reporting requirements, coordinating across Product, Legal, and external regulatory certification bodies
- Manage and refine regulatory program processes that support compliance with industry regulations
- Continuously evaluate and improve processes to ensure efficiency and effectiveness, incorporating feedback from technical and legal teams
- Manage training programs to educate relevant teams on regulatory requirements, policies, and best practices and ensure that teams understand how regulatory compliance impacts their work
- Ensure Flatiron’s adherence to all regulatory obligations
- Monitor the overall compliance of Flatiron’s regulated products and services
- Supports regulatory incidents or corrective action plans that may impact regulatory compliance, as needed
- Maintain good standing with federal regulatory certification programs, including the ONC certification program for Health IT developers
- Participate in relevant regulatory communities/industries; gathers regulatory policy intelligence and analyzes changes in the regulatory environment to inform decision making
- Drive contract lifecycle management (CLM) to ensure the timely execution of commercial agreements
- Support ongoing maintenance of CLM tool, Ironclad, across legal and all business units, configuring system and workflows to meet stakeholder needs
- Maintain contracting process documentation and provide end user training for new sales representatives and account managers
- Route contracts for signature as needed and ensure all executed agreements are correctly archived
- Establish reporting to assess CLM KPIs and drive data-driven process improvement
- Identify opportunities and lead projects to enable greater efficiency across the Legal team
- Identify and implement tools (including AI functionality) to streamline practices, as well as manage design, rollout, and training for new systems
- Assist in developing legal and regulatory knowledge management systems and practices to preserve and deploy information assets
Requirements
- 3-5 years of experience in operations, program management, or project management in a highly regulated environment (ideally health tech or healthcare)
- Familiarity with software development and contracting processes
- Willingness to learn the legal and regulatory landscape that impacts our products and services
- Robust problem solving and project management skills
- Bias for action with demonstrated success executing projects with multiple dependencies and maintaining accountability and relationships with stakeholders
- Autonomy in decision-making and execution while maintaining open communication with stakeholders, ensuring collaboration and seeking input when necessary
- Ability to identify what’s important and effectively prioritize competing workstreams
- Excellent communications skills, with the ability to synthesize, simplify, and explain complex topics to different cross-functional stakeholders
- Demonstrated ability to learn quickly in a fast-paced environment
- High degree of comfort with ambiguity and ability to quickly develop hypotheses with limited information
Skills
- Regulatory program management
- Legal operations
- Contract lifecycle management (CLM)
- Project management
- Problem solving
- Communication
- AI functionality implementation
- Knowledge management systems
Location
- Remote
- NYC
- Durham
Work Type
- Remote
- Hybrid
Experience Level
- 3-5 years
Benefits
- Work/life autonomy via flexible work hours and flexible paid time off
- Comprehensive compensation package
- 401(k) contribution
- Financial health resources including 1:1 financial advice
- Mental well-being tools and services
- Parental benefits and policies including family-building care and generous leave
- Path to parenthood programs supporting fertility, adoption and surrogacy
- Travel support for safe healthcare services
- Continuous learning support
- Diversity in the workplace support
About the Company
- Flatiron Health is improving and extending lives by learning from the experience of every person with cancer.
- We are creating a more modern, connected oncology ecosystem.