Senior Manager, Compliance Investigation

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); On-site; USD 135,000 - 201,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Tuition reimbursement

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Co., Ltd seeks a Senior Manager, Compliance Investigations to lead investigations from intake to resolution, assessing allegations and developing plans. The role reviews documentation, interviews staff, and supports corrective actions to uphold the company's compliance program.

It also oversees conflict-of-interest reviews and contributes to training and policy updates. The position reports to the Director, Compliance Investigations in the Ethics & Compliance group and

Qualifications

• Bachelor’s degree required; J.D. degree preferred.
• 3+ years of experience in compliance in pharmaceutical industry.
• Knowledge of anti-kickback statutes, False Claims Acts, PPACA, state reporting statutes, and related laws.
• Experience in end-to-end conflicts of interest process and mitigation plans.

Responsibilities

• Conduct investigations from intake through resolution, including planning and interviewing.
• Review documentation and data, assess allegations and determine findings.
• Support corrective action recommendations and policy development.
• Assist with conflicts of interest reviews from intake to final resolution.
• Develop and deliver training; monitor field activities and monitoring programs.
• Collaborate with Marketing, Sales Operations, Medical Affairs, and Sales leadership.

Skills

Compliance experience

Regulatory knowledge

Interviewing

Communication skills

Discretion

MS Office

Education

Bachelor's degree (BA/BS)

J.D. degree preferred

Tools

Microsoft Office

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
• paid leave programs
• other company provided benefits

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.

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 [e-mail].

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.