- 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
- Monitor legislative landscapes, compliance trends, and recent enforcement activities by relevant government authorities to provide updates to management
- Implement and oversee company-wide healthcare compliance program, policies, and controls
- Develop and evolve relevant and robust policies and other guidance documents to ensure compliance with applicable laws and regulations, and industry standards
- Proactively drive culture of compliance by drafting and disseminating written materials and training that are aimed at increasing stakeholders' awareness and understating of relevant regulatory requirements and industry standards
- Conduct compliance risk assessments and coordinate implementation of necessary mitigation actions, aligned with evolving regulatory requirements, industry standards, and business initiatives and strategies
- With support from Legal department, lead 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 and/or qualification of/by third parties
- Prepare and present periodic reports and status of compliance to management, including the measures and activities to ensure compliance
- Other duties as assigned
- BS or BA degree with at least 10 years of relevant experience
- Working knowledge of of Federal Anti-Kickback Law, False Claims Act, US FDA and EMA Laws and Regulations, and relevant Federal and State Consumer Protection Laws, PhRMA Code, ACCME, EFPIA, and FCPA.
- Competent knowledge of and ability to use Microsoft Office suite
- Ability to follow company procedures, work instructions, and policies
- Ability to process, synthesize and summarize complex issues
- Excellent judgment, and analytical, problem-solving skills
- Work in a safe manner; properly handle materials and chemicals
- Excellent attention to detail and organizational skills
- Ability to multi-task and prioritize work tasks with minimal supervision
- Excellent interpersonal, verbal, and written communication skills
- JD or Master's degree in relevant area
- Prior experience with use of an electronic document management system in a regulated environment
- Relevant Compliance and ethics Professional certification
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Director, Compliance - Pasadena, United States - Arrowhead Pharmaceuticals, Inc.
Description
The Position
The purpose of this position within the Quality and Compliance department is to provide leadership and oversight of healthcare compliance program and policies worldwide, with emphasis on the US healthcare compliance.
A key function of the position will involve continued development, maintenance, monitoring, and execution of the compliance program and corporate policies at Arrowhead.
This position will report to the Vice President Quality and Compliance and work closely with members of the Legal, Medical, Regulatory, Quality, and Commercial teams to promote awareness and understanding of positive ethical principles and ensure continuous suitability and alignment of compliance program framework and controls with relevant laws and company's goals.
Requirements:
Preferred:
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