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Director, Ethics & Compliance Business Partner

Somerset, New Jersey, United States

Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. 

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Director, Ethics & Compliance Business Partner as part of the Compliance team based in Somerset, NJ. 

Role Overview

Director, Ethics & Compliance Business Partner: This role is responsible for overseeing the engagement of external stakeholders, providing subject matter expertise and leading the development of both global and regional policies, training, and communications as needed, reviewing various materials, tactics, and engagement requests for compliance, and providing consultation to business partners across medical, clinical, and commercial functions. The position reports directly to the Global Head of Compliance and works closely with other senior leaders to align compliance strategies.

Key Responsibilities  

  • The Director, Compliance Business Partner is responsible for: 
    • Collaborating with the Global Operations Senior Director and other compliance leaders to ensure cohesive and integrated efforts
    • Advising internal stakeholders on compliance risks associated with external engagements
      • Overseeing the processes and systems associated with engagement of HCPs / HCOs (FMV, Contracting, etc.)
    • Guiding the development and oversight of compliance frameworks for interactions with key external stakeholders
    • Providing compliance consultation to business partners across medical, clinical, and commercial functions
    • Overseeing product material reviews to ensure compliance with corporate standards
    • Contributing to the development of compliance policies
    • Conducting live training sessions to educate business partners

Requirements

  • Solid experience in global biotech company with proven track record of managing projects requiring significant stakeholder involvement
  • Bachelors degree in related field (compliance)
  • Knowledge of OIG seven elements
  • Experience working with Commercial and Medical Affairs
  • Knowledge of adboards, speaker programs, FMV
  • Significant experience working as a compliance advisor, business partner or consultant
  • Strong understanding of compliance processes and activities common to the biotech/pharmaceutical industry
  • Strong understanding of healthcare compliance and enforcement environment
  • False Claims Act, Anti-kickback Statute, anti-bribery considerations, and CDE rules and regulations
  • Ability to develop strong trusting and productive relationships within and across the business areas to seek alignment on objectives and achieve results
  • Ability to work independently and prioritize in a rapid growth environment, with a sense of urgency
  • Excellent written and oral communication skills
  • High level of integrity with good ethical core values
  • Excellent time management and organizational skills with strong attention to detail, organizational, analytical and people skills

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#Li-Hybrid

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

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