Director of Compliance

2 weeks ago

ParsippanyTroy Hills, United States IBSA USA Full time

At IBSA we are driven by our 4 pillars: People, Innovation, Quality and Responsibility. Understanding People are our most valued asset we strive to have a strong result driven collaborative culture with a great work/life balance.


The Director, Compliance, will be responsible for establishing and updating compliance strategy and guidance for IBSA’s US commercial and medical operations in collaboration with the Global compliance team. The ideal candidate will have deep US compliance experience and prior experience building US compliance programs at a global pharmaceutical company. This individual will also exhibit exceptional dynamic range, capable of quickly pivoting between global strategy and local operational execution, with a relentless focus on ensuring that the team can meet the needs of IBSA as we continue to scale.


With our growing footprint in the US we all partake in the responsibility to drive success


Responsibilities:


  • Develop and/or update Company compliance policies, SOPs and guidelines and internal communications
  • Develop and oversee company-wide compliance training programs. This includes reviewing and updating training content, coordinating delivery through our learning management system, and creating specialized live sessions to ensure understanding of compliance laws and policies.
  • Monitor commercial and non-commercial programs for adherence to IBSA’s policies including its Code of Conduct
  • Provide compliance guidance on promotional and non-promotional materials to minimize risk and participate on promotional review committee.
  • Review and approve annual engagement plans and business needs reviews for HCP engagement in connection with Commercial, Sales and Marketing and other departments
  • Pivot fearlessly: Be prepared to adjust US compliance strategies and operations in response to new data, regulatory changes, or internal audit findings, ensuring that the organization remains agile and compliant.
  • Accept risk: Develop and implement US compliance strategies that recognize the inherent risks in the pharmaceutical industry, embracing these risks as necessary for impactful innovation and progress.
  • Provide guidance on complex compliance matters like anti-bribery, anti-corruption, conflicts of interest, and interactions with healthcare providers, ensuring consistent and practical advice.
  • Collaborate with internal legal and regulatory compliance team to implement tailored compliance initiatives and training programs.
  • Assist in drafting and updating compliance-related agreements and provide support to legal and procurement teams on compliance provisions.
  • Develop and maintain a deep comprehension of Company processes, systems, technologies, data, customers, end users, vendors, and the compliance.
  • Stay informed about industry regulations, best practices, and emerging trends in healthcare compliance and regulatory environments.
  • Conduct regular risk assessments to identify compliance issues and develop strategies to mitigate risks. Monitor and audit the effectiveness of the compliance program, and when necessary, conduct internal investigations into potential violations of our Code of Conduct and policies, working with legal counsel.


Qualifications:

  • Juris Doctor (JD) with at least 8 years of experience in legal/compliance roles within the healthcare industry or law firms, including at least 5 years specifically in pharmaceutical company compliance.
  • Strong knowledge of federal and state laws (e.g., False Claims Act, Anti-Kickback Statute).
  • Working knowledge of relevant US compliance guidelines, regulations (AKS, FCA, FDCA, HIPAA, FCPA) and PhRMA Code principles
  • Knowledge of compliance risks and considerations related to healthcare sales and marketing activities, including interactions with healthcare professionals and customers and promotional activities is highly desirable.
  • Demonstrated knowledge and hands-on experience with the foundational elements of effective compliance programs, such as developing policies/procedures, creating and delivering training, conducting risk assessments, and conducting monitoring activities.
  • Professionalism, discretion, and judgment through sound decision-making to obtain solutions through collaborative efforts across the Company.

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