What are the responsibilities and job description for the Associate Director, Compliance Applications and Data Management position at Legend Biotech US?
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 an Associate Director, Compliance Applications and Data Management as part of the Compliance team based in Remote.
Role Overview
The Associate Director, Compliance Applications, under the direction of the Sr. Director, Global Compliance Operations, will serve as System Administrator for Legend Biotech's Global Compliance systems, supporting system upgrades and day-to-day system operations and delivery of content via Compliance platforms. This role will function as a key member in the Needs Assessment/KOL tiering process and will work collaboratively with Legend Biotech A/P for SAP/Concur alignment to support Sunshine Act. Assist with other compliance related systems throughout the organization (e.g., Veeva, Sharepoint, and third-party risk management platforms). This role will also assist as needed with leading training classes for the Compliance team.
Key Responsibilities
- Collaborate with the Sr. Director, Compliance Operations and other compliance team members
- Assist with the development of policies and procedures as a SME
- Designing and delivering comprehensive compliance training programs for all employees
- Serve as Compliance Applications System Admin (ComplianceWre, SharePoint)
- Assist with future Compliance applications implementations and upgrades
- Manage the delivery of compliance communications and updates
- Oversee compliance data management and technology
- Managing the collection, storage, and analysis of compliance data, ensuring it is accurate, secure, and accessible for informed decision-making and reporting purposes
- Monitor, and revise as needed, Key Performance Indicators (KPI) for compliance training
- Work collaboratively with functional leads for procedure alignment based on roles
- Serve as subject matter expert for Compliance & Training systems
- Make recommendation for future system upgrades
- Troubleshoot problems reported by system users
- Global SME for Legend's Learning Management System LMS (ComplianceWire)
- Handle GxP Change Control for ComplianceWire updates
- Support HCP Contracts Management system
Requirements
- Bachelor's degree required in information science, data management, computer science or related field preferred
- Minimum of 7 years as a trainer/system Applications
- Minimum of 10 years in the Biotech/Pharmaceutical Industry
- Experience with Learning Management Systems
- Advanced computer skills and practical knowledge of MS Office Suite, SharePoint, and other related systems
- Ability to effectively oral and written communication skills
- Excellent organizational skills
- Willing to work in an environment where individual initiative and accountability to projects are required with limited day-to-day supervision
- Ability to effectively prioritize and execute tasks in a fast-paced environment
- Ability to work collaboratively, effectively, and productively in diverse organization structures
- Works well in a team-oriented, collaborative environment
- Ability to create and deliver presentations to management or team members
- Ability to work positively within a continually changing environment
- Ability to problem-solve
- Proactive and continuous improvement oriented
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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.
