Associate Director, Compliance Risk, Audit and Monitoring at Legend Biotech

Franklin Township, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Solid understanding of the elements of an effective compliance program
Ability to proactively drive compliance improvement with minimal supervision
Ability to work closely with all members within the global compliance team
Ability to make a mixture of independent and team decisions based on alignment within the team and the organization’s priorities

Responsibilities

Develop, implement, and conduct compliance risk assessments: identify and evaluate inherent and residual compliance risks across business units and functions; coordinate a cohesive approach to align with an Enterprise-Wide Risk Assessment
Develop, maintain, and coordinate a comprehensive audit and monitoring plan: design and execute risk-based compliance audit and monitoring activities to test control effectiveness across various business units
Collaborate with stakeholders: work closely with Internal Audit and other business units to address compliance gaps
Identify, project manage, and track compliance remediation efforts: in collaboration with applicable stakeholders and the compliance team, identify and implement corrective action necessary to address risks identified via compliance risk assessment, audit, and monitoring activities; project manage timely closure of prioritized compliance improvements
Assist with compliance investigations: assist the Senior Director Global Compliance Operations with investigations and the independent whistleblowing intake system; gather, analyze, and interpret relevant data to determine root cause issues
Drive efficiencies: review and assess all company policies to ensure alignment across global, regional, and local frameworks; analyze existing structures, identify gaps, and support the development of a cohesive governance model that promotes consistency; prepare reports, metrics, analytics, and presentations for internal and external compliance reporting to drive communications and updates across the business
Oversee corporate compliance risk assessment, audit, and monitoring activities; lead, manage, and coordinate compliance audit and monitoring activities; facilitate oversight efforts across various business units; drive company policy alignment

Skills

Key technologies and capabilities for this role

Compliance Risk AssessmentAudit ManagementMonitoring ActivitiesRegulatory ComplianceRisk MitigationPolicy DevelopmentAnalyticsPresentationsCompliance Program

Questions & Answers

Common questions about this position

What is the location for this Associate Director role?

The position is based in Somerset, NJ.

What does the role report to?

The position reports into the Senior Director Global Compliance Operations.

What are the key responsibilities of this position?

Key responsibilities include developing and conducting compliance risk assessments, creating and coordinating audit and monitoring plans, collaborating with stakeholders, managing compliance remediation efforts, and assisting with compliance investigations.

What skills or experience are needed for this role?

The role requires a solid understanding of the elements of an effective compliance program, experience in compliance risk assessment, audit and monitoring activities, project management skills, and the ability to interact across business units.

What is the salary or compensation for this position?

This information is not specified in the job description.

Legend Biotech

Develops and commercializes cell therapies

About Legend Biotech

Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.

Franklin Township, New JerseyHeadquarters

2014Year Founded

$146.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Remote Work Options

Risks

Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.

Collaboration with Multiply Labs may face technological challenges, delaying production timelines.

Financial strain from new R&D facility could affect operational focus if advancements lag.

Differentiation

Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.

The company is technology agnostic, exploring multiple platforms for effective cancer treatments.

Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.

Upsides

Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.

New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.

Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.

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