Chief Compliance Officer

The Chief Compliance Officer has worldwide responsibility for implementation and maintenance of Therakos’ Health Care Compliance (HCC) program and related policies, guidelines, practices, and processes. The role  is responsible for ensuring  among other things, Therakos meets statutory and regulatory requirements related to  the company’s interactions with Health Care Professionals (HCPs) and Health Care Organizations (HCOs), the company’s commercial and scientific activities and its compliance with the Anti-Kickback Statute, the Foreign Corrupt Practices Act and other applicable fraud, abuse, and anti- corruption laws as well as  the company’s compliance with financial disclosure and reporting mandates to governmental bodies (or designates) with respect to value transfers between Therakos and HCPs/HCOs.

The Chief Compliance Officer advises and engages with company leadership to provide sustained support for all aspects of Therakos’ HCC program including developing and implementing HCC policies, training and education on HCC principles, auditing and monitoring the company’s compliance, ensuring effective lines of communication exist for employees to report HCC-related issues to the company, publicizing standards of conduct, enforcing standards of conduct through disciplinary guidelines, and responding promptly to detected compliance issues by undertaking corrective action as appropriate. The individual will advise Senior Management and the Board of Directors on compliance related issues. The Chief Compliance Officer will prepare agendas for and serve as chair for Therakos’ Compliance Steering Committee (CSC) meetings and will implement additional policies and procedures as directed by the CSC, Senior Management and or the Board of Directors.

           Principal relationships within the Company include: engagement with the Executive Leadership Team, CEOs, Human Resources, Legal, Finance, Commercial Operations (Sales, Marketing, Ops, etc), Medical/Clinical Affairs, R&D, and managing contact with all levels of employees across the Company on HCC related matters. Role reports to Therakos’ General Counsel & EVP of Compliance

Specifically, the individual will:

·        As Chief Compliance Officer, chair the Therakos Compliance Steering Committee, which has oversight of the compliance controls across Health Care Compliance, Quality, Regulatory, Finance and Human Resource related functions.

·        Serve as the point of contact for HCC policies and procedures:

o  Develop partnerships with management teams to reinforce compliance principles and embrace ownership to make compliant decisions

o  Advise internal stakeholders of potential compliance risk areas and develop and manage risk mitigation plans

o  Effectively influence individuals at the highest levels of the organization

o  Ensure that Therakos’ business planning process includes appropriate consideration of anticipated interactions with HCPs and HCOs in order to ensure appropriate needs assessment, business justification, fair market value compensation and contracting in accordance with appropriate safe harbor provisions of the Anti-Kickback Statute

·        Responsible for providing HCC direction, guidance, support, and oversight for day to day business activities:

o  Program concepts & related materials

• Risk-based approvals for all transactions regarding value exchanges with HCPs/HCOs
• Analyzing trends from Oversight & Monitoring activities and taking action as necessary (eg., training, investigation, policy revisions/updates)
• Monitoring Therakos’ contract database and contracting process for compliance with HCC policies
• Developing an annual risk assessment and implementing it across functions

·        Provide guidance and oversight to ensure integration of appropriate HCC policies, procedures and related processes into the development of strategic and tactical plans, forecasts, call plans and incentive compensation plan, as well as oversight relating to the execution of those plans including oversight and/or review and approval of programs and processes.

• Manage HCC approval and documentation processes for business plan, call plans, and compensation plans
• Review and provide input into business strategies and tactics (needs assessment)
• Recommend and develop additional monitoring plans for high risk projects
• Identify training needs, develop and deliver appropriate HCC trainings for internal and external business partners

·        Participate on cross-functional and/or cross-company teams

• Manage and facilitate Therakos Compliance Committee
• Oversight for Educational Grant committee and other compliance review functions

• Oversee and ensure complete data is captured and accurate reports are filed to meet statutory domestic and international transparency reporting requirements (USA State reports, Sunshine, UK Bribery Act, etc).

REQUIRED:

·        Bachelors Degree

·        Health Care Compliance Certifications from Accredited Program(s)

·        10 years experience in Health Care Compliance roles with at least 2 years experience in a Health Care Compliance Leadership role with a successful record in implementing Health Care Compliance program elements

·        US HCC Experience and Leadership

·        Ability to travel, up to 20% annually

PREFERRED:

·        Masters Degree or JD

·        International HCC Experience

·        Experience in Clinical Activities

·        CCEP Certification