Senior Manager, Compliance Investigations

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Tuition reimbursement

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a Senior Manager, Compliance Investigations to lead investigations from intake to resolution and to support the conflicts of interest review process. The role ensures adherence to federal and state laws and supports the broader compliance program.

Collaboration with Marketing, Sales, Medical Affairs and leadership is essential. Responsibilities include developing investigation plans, reviewing documentation, and promoting education on compliance programs

Qualifications

• Bachelor's degree required; JD preferred.
• 3+ years of experience in pharmaceutical compliance.
• Knowledge of how pharmaceutical commercial operations function.
• Knowledge of applicable laws and regulations in compliance programs.
• Experience with conflicts of interest processes and mitigation plans.
• Strong business, legal and regulatory knowledge.
• Ability to handle confidential information with discretion.
• Excellent written and oral communication skills.
• Proficiency with Microsoft Office

Responsibilities

• Conduct compliance investigations from intake to resolution.
• Develop and implement investigation plans and interview stakeholders.
• Review relevant docs and data; determine findings; support corrective actions.
• Assist with conflicts of interest reviews from intake to resolution.
• Develop and deliver training on compliance developments and tools.
• Collaborate with Marketing, Sales, Medical Affairs and leadership to strengthen the program.

Skills

Regulatory knowledge

Compliance investigations

Communication skills

Judgment & discretion

Independence

Microsoft Office

Education

Bachelor's degree

J.D. degree preferred

Job description

Job Description:

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.

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 [e-mail].

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.