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Associate Compliance Counsel

Company: Otsuka Pharmaceutical
Location: Princeton
Posted on: January 25, 2023

Job Description:

Job SummaryThe Associate Compliance Counsel will report to Senior Compliance Counsel in the Corporate Compliance section of the Ethics & Compliance (E&C) Department to operationalize compliance with the laws, regulations, and industry codes governing commercial pharmaceutical and medical device activities, continually assess business risk, and support the development and implementation of risk mitigation strategies and tactics.Job Description

  • Reports to the Senior Compliance Counsel in the Corporate Compliance section of the Ethics & Compliance Department.
  • Supports the development and implementation of programs to ensure compliance with federal and state laws governing the pharmaceutical and medical device industries, including, but not limited to, the Anti-Kickback laws, the FCA, FDCA, FDAMA, PDMA, HIPAA, FCPA, and federal and state Sunshine laws.
  • Creates and updates policies, business rules, and training to support an effective compliance program, reinforce adherence with industry codes (PhRMA Code, AdvaMed Code, etc.), and foster a culture of integrity.
  • Monitors federal and state legislation, guidance, and enforcement activity; assesses business risk; and develops mitigation strategies and tactics.
  • Provides guidance to business partners including Marketing, Sales, and Commercial Operations on compliance policies and remediation activities.
  • Tracks and operationalizes compliance with state laws and regulations on drug price transparency, representative licensure and disclosure, limitations on transfers of value, etc.
  • Supports industry benchmarking initiatives and analyses.
  • Develops and presents compliance training to field-based Commercial colleagues. Develops and delivers training or other methods to ensure all colleagues are educated regarding current developments in compliance, including developing tools for use by the Ethics & Compliance Department.
  • Provides support for field monitoring and record auditing activities as needed.
  • Provides additional support to the Ethics & Compliance team as needed.QualificationsRequired
    • Juris Doctorate degree
    • At least 3 years of substantive experience in life sciences commercial compliance, in-house at a pharmaceutical or medical device company and/or at a firm counseling life sciences industry clients.
    • In-depth understanding of US healthcare industry laws and regulations.
    • Demonstrated achievement monitoring and mitigating regulatory risk and fostering a culture of compliance.
    • Strong interpersonal, writing, communication, organizational, project management and presentation skills.
    • Experience in handling confidential and sensitive situations or information with an ability to exercise a high degree of judgment and discretion.
    • Up to 10% travel based on business needs.Come discover more about Otsuka and our benefit offerings; job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Valid Proof of COVID-19 Vaccination or AccommodationThe COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.Statement Regarding Job Recruiting Fraud ScamsAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at:, or your local authorities.

Keywords: Otsuka Pharmaceutical, Trenton , Associate Compliance Counsel, Legal , Princeton, New Jersey

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