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Director, Ethics & Compliance Business Partner

Bridgewater, New Jersey, United States

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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

 

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). 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 Bridgewater, NJ.

 

Role Overview

This role directly supports the Commercial and Medical teams and oversees the engagement of external stakeholders, providing subject matter expertise and leading the development of 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

 

  • Embedding seamlessly with the business to provide clear, timely, and solutions-oriented compliance advice.
  • Providing thought leadership on emerging risks and enforcement trends as the business evolves.
  • 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.
  • 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

 

  • Bachelor’s degree in related field (compliance); Masters degree in business or accounting or JD preferred. 
  • 8+ years compliance and/or pharmaceutical industry experience.
  • Solid experience in global pharmaceutical company with proven track record of managing projects requiring significant stakeholder involvement.
  • Extensive experience advising Commercial and Medical Affairs .
  • Knowledge of adboards, speaker programs, FMV compliance principles .
  • Strong understanding of compliance processes and activities common to the U.S. biotech/pharmaceutical industry.
  • Strong understanding of healthcare compliance and enforcement environment.
  • High degree of familiarity with False Claims Act, Anti-kickback Statute, anti-bribery considerations, and CDE rules and regulations.
  • Understanding of how to efficiently operationalize OIG’s seven elements.
  • Team player with proven ability to develop trusting and productive relationships within and across the business areas to seek alignment on objectives and achieve results .
  • Ability to work independently and prioritize projects in a rapid growth environment as well as exercise sound judgment as to when to escalate matters to management.
  • 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.
  • Sense of humor.

 

 

#Li-LB1

#Li-Hybrid

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$193,629 - $254,137 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

 

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

 

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

 
For information related to our privacy notice, please review: Legend Biotech Privacy Notice.

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I (the candidate) enter into this Non-Disclosure Agreement (the “Agreement”) with Legend Biotech USA Inc. (the “Company”), effective as of the date of my acknowledgement below, for the purpose of enabling the Company to evaluate a possible employment relationship with me.

  1. Access to Company Confidential Information. I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below.  I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a) not use or disclose any Confidential Information; (b) keep all Confidential Information confidential at all times; and (c) not copy, reproduce or modify any Confidential Information.
  2. Definition of “Confidential Information.” For purposes of this Agreement, “Confidential Information” shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know-how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof; provided, however, that “Confidential Information” shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure.
  3. Third Party Information. I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer.  I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public.
  4. Remedies for Breach. I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Company’s right to obtain such relief shall not limit its right to obtain other available remedies.
  5. General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California.  This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company.

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