Executive Director, Compliance Officer
Job description
The Executive Director, 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 Executive Director, 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 Executive Director, 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.
Job requirements
REQUIRED:Bachelors DegreeHealth 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 elementsUS HCC Experience and LeadershipAbility to travel, up to 20% annually PREFERRED:Masters Degree or JDInternational HCC ExperienceExperience in Clinical ActivitiesCCEP Certification
Job responsibilities
Specifically, the individual will: As Executive Director, 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:Develop partnerships with management teams to reinforce compliance principles and embrace ownership to make compliant decisionsAdvise internal stakeholders of potential compliance risk areas and develop and manage risk mitigation plansEffectively influence individuals at the highest levels of the organizationEnsure 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:Program concepts & related materialsRisk-based approvals for all transactions regarding value exchanges with HCPs/HCOsAnalyzing 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 policiesDeveloping 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 projectsIdentify training needs, develop and deliver appropriate HCC trainings for internal and external business partners Participate on cross-functional and/or cross-company teamsManage 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).
Job benefits
Job Benefits:
Medical, Dental, Vision
Insurance
Life/AD&D
Short- and Long-Term
Disability
401(K) with large company
match
Health Saving Account (HSA)
and Flexible Spending Account (FSA) with company match
Wellness Program
Employee Assistance Program
(EAP)
Generous Paid Time Off (PTO)
Disclaimer: The
included statements are intended to describe the general nature and level of
work being performed by employees assigned to this classification. They are not
intended to be construed as an exhaustive list of all responsibilities, duties
and skills required of employees assigned to this position.
Apply Now
The Executive Director, 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 Executive Director, 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 Executive Director, 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.
Job requirements
REQUIRED:Bachelors DegreeHealth 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 elementsUS HCC Experience and LeadershipAbility to travel, up to 20% annually PREFERRED:Masters Degree or JDInternational HCC ExperienceExperience in Clinical ActivitiesCCEP Certification
Job responsibilities
Specifically, the individual will: As Executive Director, 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:Develop partnerships with management teams to reinforce compliance principles and embrace ownership to make compliant decisionsAdvise internal stakeholders of potential compliance risk areas and develop and manage risk mitigation plansEffectively influence individuals at the highest levels of the organizationEnsure 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:Program concepts & related materialsRisk-based approvals for all transactions regarding value exchanges with HCPs/HCOsAnalyzing 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 policiesDeveloping 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 projectsIdentify training needs, develop and deliver appropriate HCC trainings for internal and external business partners Participate on cross-functional and/or cross-company teamsManage 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).
Job benefits
Job Benefits:
Medical, Dental, Vision
Insurance
Life/AD&D
Short- and Long-Term
Disability
401(K) with large company
match
Health Saving Account (HSA)
and Flexible Spending Account (FSA) with company match
Wellness Program
Employee Assistance Program
(EAP)
Generous Paid Time Off (PTO)
Disclaimer: The
included statements are intended to describe the general nature and level of
work being performed by employees assigned to this classification. They are not
intended to be construed as an exhaustive list of all responsibilities, duties
and skills required of employees assigned to this position.
Apply Now