Senior Manager, Compliance Investigations

Posted 2 Days Ago
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Princeton, NJ, USA
In-Office
135K-201K Annually
Senior level
Internet of Things • Pharmaceutical
The Role
Conduct pharmaceutical compliance investigations from intake through resolution, including allegation assessment, planning, interviews, document and data review, findings, and corrective actions. Support conflicts-of-interest reviews, compliance monitoring, policy development, training, reporting, and process improvements. Partner with Marketing, Sales Operations, Medical Affairs, and sales leadership while ensuring compliance with pharmaceutical and medical device laws and regulations.
Summary Generated by Built In

Job Description:

The Senior Manager, Compliance Investigations will conduct compliance investigations from intake through resolution, including assessing allegations, developing investigation plans, conducting interviews, reviewing relevant documentation and data, determining findings, and supporting corrective action recommendations. 

  • This role will support the compliance investigation function to ensure implementation of appropriate policies and procedures, maintain a system of reporting, and ensure the integrity of all compliance investigations. 
  • This role will help ensure the Company’s Compliance Program effectively promotes prevention, detection, and resolution of instances of improper conduct to ensure conformity to state or federal laws, regulatory requirements, and the standards of conduct. 
  • This role will also support the conflicts of interest review process from intake to final resolution, including monitoring recurring conflict themes and systemic issues and proposing process or control improvements.  
  • Reports to the Director, Compliance Investigations in the Ethics & Compliance group. 
  • Support the development and implementation of programs to ensure compliance with federal and state laws governing the pharmaceuticals and medical device businesses, including, but not limited to, the Anti-Kickback laws, HIPAA, the FCA, the PDMA, the FDCA, FDAAA, the FCPA, and the federal Sunshine Act. 
  • Support the Director, Compliance Investigations through interactions with business partners such as Marketing, Sales Operations, Medical Affairs, and Sales leadership. 
  • Provide support for field monitoring activities such as compliance ride alongs, speaker program monitoring, record reviews of call notes and emails, and other activities. 
  • Assist with creation and revision of policies and procedures supporting the elements of an effective compliance program. 
  • Develop and deliver training or other methods to ensure all colleagues are educated regarding current developments in compliance including developing tools for use by internal customers. 

 

Required:  

  • Bachelor’s degree (BA, BS) required, J.D. Degree preferred
  • 3+ years of experience in compliance in pharmaceutical industry (medical device experience is preferable as well). 
  • Knowledge of how pharmaceutical commercial operations function, and how compliance programs are effectively developed, communicated and managed.
  • Knowledge of applicable laws and regulations, industry guidelines and best practices in compliance programs, including anti-kickback statutes, False Claims Acts, Patient Protection and Affordable Care Act (PPACA), state reporting statutes, and other laws.  

  • Knowledge of end-to-end conflicts of interest process, including evaluating employee disclosures, analyzing compliance risks, and executive formal mitigation plans.  

  • Strong business, legal and/or regulatory knowledge 

  • Experience in handling confidential and sensitive situations or information with ability to exercise a high degree of judgment and discretion. 

  • Must be able to exercise appropriate judgment, as necessary.

  • High level of initiative and independence.

  • Excellent written and oral communication skills

  • High degree of proficiency with Microsoft Office Suites

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits:  Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.


Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591

Disclaimer: 


This 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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

 

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting [email protected]

Statement Regarding Job Recruiting Fraud Scams

At 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 https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka 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: https://www.ic3.gov,  or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Skills Required

  • Bachelor's degree (BA or BS)
  • J.D. degree
  • 3+ years of compliance experience in the pharmaceutical industry
  • Medical device compliance experience
  • Knowledge of pharmaceutical commercial operations and compliance program development, communication, and management
  • Knowledge of applicable laws, regulations, industry guidelines, and compliance best practices
  • Knowledge of end-to-end conflicts of interest processes
  • Strong business, legal, and/or regulatory knowledge
  • Experience handling confidential and sensitive information with judgment and discretion
  • Ability to exercise appropriate judgment
  • High level of initiative and independence
  • Excellent written and oral communication skills
  • High proficiency with Microsoft Office Suite

Otsuka America Pharmaceutical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Otsuka America Pharmaceutical and has not been reviewed or approved by Otsuka America Pharmaceutical.

  • Healthcare Strength Health coverage spans medical, dental, vision, prescription services, telehealth, life insurance, and disability, with notable mental‑health access through therapy, coaching, and digital tools. Wellness resources such as fitness reimbursement, nutrition support, and caregiver assistance further reinforce overall healthcare robustness.
  • Retirement Support Retirement offerings include a strong 401(k) match alongside personalized financial counseling for tax planning, education funding, home buying, and estate planning. These features position retirement support as a differentiator within the total rewards package.
  • Leave & Time Off Breadth Time‑off policies include flexible time off, paid holidays, volunteer time off, and a company winter holiday break. The breadth of leave programs supports work–life balance across various needs.

Otsuka America Pharmaceutical Insights

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The Company
HQ: Princeton, NJ
3,516 Employees
Year Founded: 1989

What We Do

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.

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