Senior Manager, Healthcare Compliance

The Position

The purpose of this position within the Quality and Compliance department is to support the development and ongoing management of Arrowhead's healthcare compliance and data privacy programs and policies worldwide. A key function of the position will involve supporting the development, maintenance, monitoring, and execution of the compliance program and corporate policies at Arrowhead.

This position will report to the Director of Compliance and will work closely with members of the Legal, Commercial, Medical Affairs, Regulatory, Quality teams to promote awareness and understanding of positive ethical principles and ensure continuous suitability and alignment of compliance program framework and controls relevant laws and company's goals.

This role can be based in Pasadena or San Diego, California, with an expectation to be in office 5 days a week.

Responsibilities

• Serve as an internal subject matter expert in the field of healthcare compliance and advise internal stakeholders and management on matters related to healthcare compliance.
• Support the implementation of company-wide healthcare compliance and data privacy program, policies, and controls.
• Support the development and implementation of relevant and robust policies and other guidance documents to ensure compliance with applicable laws and regulations, and industry standards.
• Drive culture of compliance by developing written materials and training that are aimed at increasing stakeholders' awareness and understanding of relevant regulatory requirements and industry standards.
• Support audit action plans and/or corrective action plans, including designing remedies and supporting the business in implementing, tracking and completing their plans as required.
• Conduct compliance risk assessments and coordinate implementation of necessary mitigation actions, aligned with evolving regulatory requirements, industry standards, and business initiatives and strategies.
• Support the Director of Compliance and Legal department in conducting internal investigations related to the compliance program and if required, implementation of applicable corrective and preventative measures and reporting to relevant government agencies.
• Participate in the due diligence of third parties engaged in activities related to healthcare compliance and/or data privacy.
• Prepare and present periodic reports and status of compliance to management, including the measures and activities to ensure compliance.
• Other duties as assigned.

Requirements:

• Bachelor's degree in business, healthcare, or related area of study,
• 5 years of relevant experience.
• Working knowledge of Federal Anti-Kickback Law, False Claims Act, US FDA and EMA Laws and Regulations, Transparency reporting laws, relevant Federal and State Consumer Protection Laws, PhRMA Code, ACCME, and EEPIA standards.
• Competent knowledge of and ability to use Microsoft Office suite.

Preferred:

• Prior experience with use of an electronic document management system in a regulated environment
• Relevant Compliance and ethics Professional certification
• Masters Degree