Director, US Business Ethics

Title:

Director, US Business Ethics

Company:

Ipsen Bioscience, Inc.

Job Description:

The Director, U.S. Business Ethics, will play a lead role in helping to promote and enhance a culture of compliance and ethics. The Director will contribute to the continuous enhancement of an effective and data- driven Business Ethics and Compliance Program across the United States.

Main Responsibilities & Job Expectations

Work in close collaboration with Business Units, as well as Medical Affairs and Patient Advocacy teams, as a business partner to:

• Understand and anticipate the needs of business unit stakeholders
• Identify and mitigate ethics and compliance risks
• Guide ethical and compliant decision-making and behavior
• Enhance a strong ethical culture to advance ownership and accountability
• Promote effective cross-functional initiatives

Contribute to the enhancement of the Ipsen’s US Business Ethics Program by, including but not limited to:

• support the annual risk assessment process
• support training and communications
• support monitoring efforts
• Proactively identify potential areas of compliance, vulnerability, and risk
• Implement remedial/mitigation action plans
• Support country investigations in working with Global Investigations, as needed
• Support preparation for quarterly Business Ethics Committee meetings
• Lead ethical culture initiatives and assess progression against HHS OIG standards for elements of an effective compliance program
• Support and cascade Ipsen’s Global Business Ethics & Compliance Program within the U.S. and collaborate with the Global Business Ethics team on global initiatives
• Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including Federal Sunshine Act (Open Payments), State Laws (restrictions, licensures, and reporting), Industry Guidance (PhRMA Code), and applicable federal laws (Anti-Kickback Statute, FDCA, HIPAA, etc.)

Knowledge, Abilities & Experience

• BA/BS degree is required; MBA or master’s degree is a plus
• 12 to 15 years of related experience , with at least 8 years of healthcare ethics and compliance experience
• A minimum of 3 years in-house experience with a biotech or pharmaceutical company
• Experience in creating and implementing business ethics programs
• Experience as an Ethics & Compliance Advisor / Officer for Commercial and Medical Affairs functions
• Ability to travel 10-15% of the time, both domestically and internationally

Key Technical Competencies Required

• Proven leadership and communication skills, particularly in communicating with senior leaders.
• Expertise in providing sound, ethical advice to management on a broad range of business issues.
• Strong team-playing skills and the ability to participate and influence within large working groups
• Ability to address multiple and complex ethical and compliance issues.
• Ability to summarize, transform and communicate complex messages into pragmatic language and educational tools, for ensuring easy access to rules.
• Strong communication and listening skills, the ability to train a large audience, respond to questions, and present complex matters to management.
• Outstanding project management, organizational and management skills.
• Ability to exercise good judgment in challenging or adverse situations, while remaining solution- oriented.
• Ability to see the bigger picture; well-organized and focused on results.
• Ability to build consensus and respectfully driven decision- making while gaining agreement regardless of issue popularity.
• Highest personal integrity and ethics; exceptional sense of judgment and discretion.
• Ability to handle highly confidential and sensitive information with discretion.
• Demonstrated knowledge and understanding of the Food, Drug, and Cosmetic Act, U.S. Federal Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, and HIPAA.
• Demonstrated knowledge and experience with the Federal Physician Payments Sunshine Act (Open Payments) and State Laws (restrictions, licensures, and reporting)
• Broad pharmaceutical compliance experience interacting with field teams (sales, educators), marketing brand teams, Medical Affairs/HEOR, and Market Acc