Senior Manager, Compliance Investigation
Otsuka Pharmaceutical Co., Ltd.
Summary
The 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.
Job description
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.
Requirements
- Bachelor's degree (BA, BS) required
- J.D. Degree preferred
- 3+ years of experience in compliance in pharmaceutical industry
- Medical device experience is preferable
- Knowledge of how pharmaceutical commercial operations function
- Knowledge of 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
Benefits
- Medical, Dental & Vision
- Prescription Drug Coverage
- Basic Life Insurance
- AD&D Insurance
- Short-term Disability
- Long-term Disability
- Tuition Reimbursement
- Student Loan Assistance
- 401(k) Matching
- Flexible Time Off
- Paid Holidays
- Paid Leave Programs
Company overview
Otsuka Pharmaceutical Co., Ltd. is a leading Japanese pharmaceutical company headquartered in Tokyo, Japan. Founded on August 10, 1964, the company operates as a wholly owned subsidiary of Otsuka Holdings Co., Ltd. With approximately 5,907 employees as of December 2024, Otsuka Pharmaceutical specializes in the research, development, manufacturing, and marketing of pharmaceutical products, clinical testing equipment, medical devices, food products, and cosmetics. The company has established a strong global presence with operations spanning multiple countries and regions. Otsuka is particularly known for its innovative approach to healthcare, focusing on both pharmaceutical treatments and nutraceutical products that support everyday health maintenance. The company's diverse portfolio includes well-known brands and has made significant contributions to various therapeutic areas, demonstrating its commitment to improving global health through scientific innovation and quality healthcare solutions.