Director, Compliance

Alternative Resources Company

Director, Compliance

Director, Compliance
 
Summary
 
Under the direction of Corporate Counsel, the Compliance and Privacy Director will be responsible for the Corporate Compliance Program by directing various global compliance initiatives and managing the implementation and adoption of updated processes across the organization. The Corporate Compliance Program includes policies, education, training and establishing processes to smooth the way for an organizational culture of compliance. The successful candidate will have previous industry experience with U.S. pharmaceutical and medical device regulations, Federal and State False Claims Act, Sunshine Act as well as data protection and privacy laws (HIPAA, GDPR).
 
Essential Functions
  • Develop and implement new, or update existing, practices/policies to comply with personal data privacy and protection regulations, such as HIPAA and Global Data Protection Regulation.
  • Draft or update and disseminate other healthcare and compliance-related activities and policies.
  • Assess compliance-related educational needs and develop, implement, maintain and oversee training and education programs for compliance and privacy issues for the organization, including new employee orientation, annual online training and department-specific training.
  • Oversee and monitor ongoing privacy and data protection compliance activities. Work with Data Protection Officer and cross-functionally with other departments to ensure compliance with policies and procedures.
  • Collaborate with business partners providing strategic guidance on commercial programs, initiatives and processes that have health care compliance-related implications such as sales training documents, brand business plans, field incentive compensation programs, and field call plans to facilitate compliant growth.
  • Work cross-functionally with stakeholders to manage the activities of the global transparency reporting initiatives to ensure accurate and timely reporting of spend related to health care professionals are submitted in compliance with U.S., state, and other country-specific “Sunshine” laws.
  • Develop and implement compliance data analytics and reporting and provide accurate and timely analysis of transparency reporting data to internal stakeholders.
  • Conduct risk assessments and develop work plans to address identified risks, including conducting audits and monitoring and tracking activities.
  • Anticipate potential problems and proactively take appropriate steps.
  • Ensure there is a mechanism in place for appropriately disciplining instances of non-compliance and ensuring consistency in the application of disciplinary action
  • Communicate company healthcare compliance standards and information updates on new laws and guidance to committee members, key business partners and agencies
  • Assist with other legal and compliance department projects and tasks, as required.
Qualifications
  • Bachelor’s degree required with 8-10 years of experience in a compliance or legal business function in pharmaceutical and medical device industry
  • Pharmaceutical industry experience is absolutely required for this role
  • Knowledge of laws (FD&C Act, Federal and State Anti-kickback Statutes, Sunshine transparency reporting laws, False Claims Act, Foreign Corrupt Practices Act), regulations, industry guidance and best practices regarding compliant sales, marketing, and medical activities
  • Knowledge of global privacy and data protection laws, including U.S. state, Federal, HIPAA, and EU GDPR
  • Ethical, with a strong understanding of compliance risks, and a good sense for practical solutions; business friendly and pragmatic
  • Ability to grasp best practices and use them to provide client solutions.
  • Excellent organizational and project management skills, highly analytical with attention to detail and accuracy
  • Ability to review and synthesize data into meaningful reports
  • Communicate clearly, concisely and effectively; experience in business presentations
  • Proactive, flexible, responsive, resourceful and ability to work independently
  • Must be willing to travel up to 30%