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Associate Director, Compliance at Taiho Oncology

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Princeton, New Jersey





Job Description:

Looking for a chance to make a real
difference in the oncology space? Taiho Oncology is on a mission: to improve
the lives of cancer patients, their families, and caregivers. Our “People
first” approach means we also value our employees, who work relentlessly to
help us execute our mission. Taiho’s success is founded on ensuring we always
act with accountability, collaboration, and trust. By following these guiding
principles, we earn and maintain the confidence of our patients, our partners,
and each other. Together, we’re working to discover and develop innovative
cancer treatments that address unmet patient needs and apply the science behind
them in novel ways. As the field of cancer treatment evolves, we evolve with
it. Advanced technology, dedicated investigators, and incomparable facilities:
these vast resources empower us to redefine the way the world treats cancer.
It’s our work, our passion, and our legacy. If the prospect of being part of
this sounds exciting, we invite you to join us.   
 

Hybrid Role: Office/Work from Home

Position
Summary:
       

The Associate Director, Compliance reports to the Vice President
and Compliance Officer with additional oversight by the Senior Vice President
and General Counsel.  The Associate
Director is responsible for assisting the Compliance Officer in implementing a
comprehensive compliance program that is consistent with current industry best practices
and government guidance, e.g., the U.S. Sentencing Guidelines and HHS OIG
Compliance Guidance for Pharmaceutical Manufacturers, i.e., “The Seven
Elements”. 

The Associate Director, Compliance will under the guidance and
direction of the Compliance Officer: partner with assigned business areas to
provide functional Compliance guidance; provide guidance on proposed business
strategies and programs, identify legal and regulatory issues, analyze
alternatives and work with legal and other functions to propose appropriate
solutions, provide recommendations for compliant business activities, and
facilitate risk-based decision making; participate in policy and procedure
reviews and, as needed, update policy and functional procedures ensuring
relevance, clarity, and compliance; develop/update and deliver compliance
training regarding policies, procedures, and the current compliance
environment.   

Additionally, the Associate Director, Compliance will assist with:
risk assessments and trend analysis; investigations, and audits; and develop
and implement corporate and/or functional monitoring plans. 
 

Responsibilities
and Duties:
 


  • Partner
    with assigned business areas to provide functional Compliance guidance;

  • Provide
    guidance on proposed business strategies and programs,

  • Identify
    legal and regulatory issues, analyze alternatives and work with legal and other
    functions to propose appropriate solutions, provide recommendations for
    compliant business activities, and facilitate risk-based decision making;

  • Participate
    in policy and procedure reviews and, as needed, update policy and functional
    procedures ensuring relevance, clarity, and compliance; develop/update and
    deliver compliance training regarding policies, procedures, and the current
    compliance environment.

  • Assist
    with risk assessments and trend analysis; investigations, and audits.

  • Develop
    and implement corporate and/or functional monitoring plans.  

  • Directly supervise transparency report compilation and
    filing.

 

Educational
Requirements:
  

  • Bachelor’s Degree required

Experience: 


  • A
    minimum of 3 years of experience in a healthcare compliance role in a pharmaceutical
    or life sciences organization or 5 years in a related role.

  • Familiarity
    with healthcare compliance related regulations is a must have.

  • Additional experience in commercial, operational, financial,
    quality assurance, regulatory affairs preferred.

  • Strong
    working knowledge of the drug development process and commercial regulations in
    the USA is required.

  • Direct
    work experience with US and/or EU Regulatory authorities is highly preferred.

  • Highly
    detail and quality oriented.

  • Excellent
    communication and presentation skills.

  • A
    positive attitude, flexibility and a proactive thought process.

  • Experience and comfort with risk-based decision making preferred.





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