Associate Compliance Counsel
Company: Otsuka Pharmaceutical
Posted on: January 25, 2023
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
- 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
- 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
- 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
- In-depth understanding of US healthcare industry laws and
- 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
- Up to 10% travel based on business needs.Come discover more
about Otsuka and our benefit
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
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: https://www.ic3.gov, or your
Keywords: Otsuka Pharmaceutical, Trenton , Associate Compliance Counsel, Legal , Princeton, New Jersey
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