Manager, Corporate Compliance

Manager Corporate Compliance

The Manager Corporate Compliance will oversee business compliance with Otsuka policies and procedures governing fee-for-service arrangements with healthcare professionals (HCPs) and financial sponsorship of healthcare organizations and events, and other U.S. Ethics & Compliance (E&C) processes in furtherance of U.S. and global fraud and abuse risk mitigation, financial transparency, and Otsuka ethical standards.

Reports to Director Corporate Compliance.

Responsible for reviewing all HCP engagements along the product commercialization lifecycle for multiple therapeutic areas (TAs) to ensure alignment with Otsuka policies and approved business plans.

Facilitates business compliance with crossborder (ex-U.S.) engagement review and disclosure processes to ensure Otsuka's global engagements adhere to applicable local regulations and industry codes.

Advises E&C Compliance Counsel regarding HCP activities, utilization, spend, and associated risks.

Tracks and monitors business compliance with state drug price transparency requirements and state pharmaceutical representative licensure and disclosure requirements.

Tracks and logs federal and state fraud and abuse enforcement activities.

Develops and maintains E&C's business guidance repository.

Assists Compliance Counsel and Investigation teams to develop enterprise compliance policies and training materials.

Lead AI optimization initiative to improve searchability of compliance policies.

Otherwise assists the U.S. E&C Corporate Compliance Counsel team as needed.

Required

5 years paralegal experience

At least 3 years of substantive legal and / or compliance experience in the life sciences industry, in-house at a pharmaceutical or medical device company and / or at a firm counseling life sciences clients.

Understanding of the key statutes and regulations governing the U.S. pharmaceutical industry, including the federal False Claims Act; Anti-Kickback Statute; Food, Drug, & Cosmetic Act; Prescription Drug Marketing Act (PDMA); and Health Insurance Portability and Accountability Act (HIPAA)

Familiarity with federal and state aggregate spend reporting laws and requirements.

Experience with the PhRMA Code (or AdvaMed Code) on Interactions with Healthcare Professionals.

Demonstrated achievement enabling compliance with laws, guidance, and industry codes; identifying and mitigating business risk; educating business stakeholders and achieving compliant solutions for business problems.

Strong interpersonal, analytical, writing, communication, organizational, project management and presentation skills.

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

Up to 10% travel based on business needs.

Preferred

Familiarity with U.K. Prescription Medicines Code of Practice Authority (PMCPA).

Experience utilizing business systems (finance, contracting, etc.) and analytical tools such as dashboards and spreadsheets.

Experience collaborating with other enabling functions (Legal, Finance, Human Resources, Information Technology, etc.) to foster business compliance and an organizational culture of integrity.

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 $104,640.00 - Maximum $156,400.00, 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.

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 Accommodation Request.

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