Job title:
Associate Director, US Business Ethics Monitoring
Company
Ipsen
Job description
Title: Associate Director, US Business Ethics MonitoringCompany: Ipsen Bioscience, Inc.Job Description:We are seeking an Associate Director, Operations and Monitoring , U.S. Business Ethics, to help promote and enhance a culture of compliance and ethics in Ipsen’s U.S. organization. The AD will contribute to the continuous enhancement of an effective and data-driven Business Ethics and Compliance Program across the United States, with a particular emphasis on ensuring smooth and efficient operation of the US Business Ethics function and tactical support of Ipsen’s updated monitoring program.Main Responsibilities & Job ExpectationsWork in close collaboration with Monitoring Lead to:
- Understand and anticipate risks faced by business unit stakeholders
- Identify those risks via a monitoring program tailored to those risks
- Help deliver regular reporting to US BE team by explaining trends in monitoring findings and supporting Monitoring Lead in efforts to continuously improve based on those risks in real time
- Support Monitoring Lead in ensuring that actions following monitoring findings, such as remedial and mitigation plans, comply with relevant policies or SOPs that govern consequence management (e.g., discipline)
- Promote organizational effectiveness via efficient management of department meetings
- Support improvement of Ipsen’s program for tracking fee-for-service engagements with healthcare professionals, healthcare organizations, and patients, including review of fair market value
- Support Head of US Business Ethics in ensuring up-to-date tracking of department budget
- Collaborate with Monitoring Lead to integrate relevant data and technology into monitoring plans, consistent with guidance from the Office of the Inspector General of the US Dept. of Health and Human Services (“HHS-OIG”)
- Support US Business Ethics team on live monitoring to supplement external resources (speaker programs, congresses, advisory boards, and field rides).
- Contribute to the enhancement of Ipsen’s US Business Ethics Program, e.g., by supporting the annual risk assessment process
- Support country investigations in working with Global Investigations, as needed
- Support preparation for quarterly Business Ethics Committee meetings
- Contribute to 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
- Develop 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; advanced degree is a plus
- A minimum of 8+ years experience in a compliance role with at least 2 years of in-house experience in a pharma/biotech company
- Experience in creating and implementing business ethics programs is a plus
Ability to travel 15-20% of the time, both domestically and internationallyLocal to the Cambridge, MA area with ability to work a hybrid model including 2 to 3 days per week in officeKey Technical Competencies Required
- Expertise in providing sound, ethical advice 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 and respond to questions.
- 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.
- Willingness to develop 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.
- Willingness to develop 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 Access.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Expected salary
Location
Cambridge
Job date
Fri, 20 Dec 2024 23:25:30 GMT
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