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
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
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 a global biotech company with a proven track record of managing projects requiring significant stakeholder involvement
Bachelor's degree in a 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
Familiarity with 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 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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