Workly

Director, Compliance

At Cognoa

USA Only

About Cognoa:

Cognoa is a leading digital behavioral health company developing diagnostic and therapeutic solutions for children living with autism and other behavioral health conditions. For more information, please visit https://www.cognoa.com/.

Digital medicine is a relatively new healthcare and business paradigm. Our team brings together experts in the fields of AI, technology, and clinical drug development and commercialization. This new configuration of skills and experiences has led to exciting opportunities and has also generated unique and interesting challenges. We are looking for new colleagues excited to help us tackle those challenges and improve the lives of our patients and their parents.

Description:

The Compliance Director will be responsible for assisting in the development and oversight of the Company's Comprehensive Compliance Program, in preparation for its first commercial launch. Specific responsibilities include policy and process implementation, leading effective training programs, conducting internal monitoring, directing investigations and corrective actions as needed, and facilitating various risk management committees to help ensure organizational compliance with applicable laws, regulations, industry guidance and Company Policies. Reporting to the General Counsel and Chief Compliance Officer, this person will work closely and cross-functionally with management peers and functional units throughout our organization to lead and support compliance initiatives, and to raise the level of awareness of compliance within our organization.

Responsibilities:

  • Assist with the development, implementation and oversight of the Company's Comprehensive Compliance Program;
  • Analyze and interpret applicable law, regulations, and related compliance landscape and provide practical, timely solutions to meet business needs;
  • Prepare and provide compliance training materials;
  • Champion a corporate culture in which employees recognize compliance as aligned with Company core values, and regard compliance as a key factor in business decisions;
  • Facilitate the Company's Compliance Committee and provide ongoing risk management input on business strategies and operations;
  • Lead the set up of the Company's transparency reporting systems in preparation for first launch of commercial product;
  • Develop and participate in various risk management processes including review of promotional, medical and corporate materials, grant review, and federal and state transparency reporting;
  • Help manage Whistleblower Hotline and Open Door communication mechanisms;
  • Support investigations regarding matters of observed, reported or suspected non-compliance;
  • Execute monitoring plans, including ride-alongs for customer-facing remote employees.

Qualifications:

  • Advanced degree preferred; J.D. a plus.
  • A minimum of 5 years' experience as a compliance officer in a medical device/biotech/pharma organization, including demonstrated mid-level leadership.
  • Experience with medical devices/diagnostics preferred.
  • Excellent interpersonal skills; ability to develop important relationships with key stakeholders.
  • Good conflict management and negotiation skills.
  • Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
  • Seasoned in the development, initiation, maintenance, and revision of policies and procedures for the general operation of a Compliance Program and its related activities to help detect and prevent illegal, unethical, or inappropriate conduct.
  • Experience with investigations and supporting the investigative process, including management and tracking of the investigation lifecycle and close-out process.
  • Demonstrated experience working with other compliance professionals, business leaders, attorneys, and regulators.
  • A solutions-oriented collaborator.
  • Exceptional written, verbal, and presentation skills.
  • Physical Requirements:
  • Ability to sit for prolonged periods of time

Cognoa is an equal opportunity employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or another non-merit factors.

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