Senior Associate, Healthcare Law Compliance Monitoring

The Senior Associate, Healthcare Law Compliance Monitoring will be responsible to:

·        Using independent judgment, assist in execution live compliance monitoring of both promotional and non-promotional field-based activities and personnel to ensure interactions with Healthcare Professional (HCPs), Healthcare Organizations (HCOs), patients and caregivers, and internal matrix teams are compliant with relevant laws and regulations (e.g., Anti-Kickback Statute, False Claims Act, Office of Inspector General (OIG) Guidance for Pharmaceutical Manufacturers, PhRMA Code, Federal Food, Drug, and Cosmetic Act (FDCA) and the Prescription Drug Marketing Act (PDMA)) and company policies and guidance.

·        Provide administrative support for remediation activities related to live monitoring to effectively mitigate identified risks, including support in preparation of materials for coaching conversations.

·        Assist with reviewing and organizing quarterly transactional analysis of data related to business activities such as email, expenses, call notes, and speaker programs to identify potential instances of non-compliance, risk, and trends.

·        Assist in analyzing data and preparing reports that summarize areas of non-compliance and risks identified from HLAM activities.  

·        Support compiling and updating predefined monitoring metrics and reports for updates to the Sr. Director, HLAM and U.S. E&C Leadership and help identify potential compliance risks and areas of opportunity.

·        Assist with periodic operational audit transactional testing and/or other reviews of business activities.

·        Establish and maintain effective relationships with internal stakeholders and collaborate with internal partners on compliance matters.  Escalates issues and findings to senior team members for review and decision-making

·        Develop foundational knowledge of relevant trends, laws, and regulations pertaining to healthcare law and regulatory compliance in the pharmaceutical industry.

·        Support the GRC team with other assignments as needed.

 

Qualifications

Required

• Bachelor's degree in a related field
• 4+ years experience
• Able to work independently as an individual contributor and in a team setting
• Strong verbal and written communications skills to communicate clearly and effectively
• Strong organizational, interpersonal and project management skills
• Comfortable with data analysis, including ability to work with large amounts of data and organize results in a meaningful way to identify trends and potential red flags
• Up to 50% domestic travel.

Preferred

• Pharmaceutical, healthcare, or related industry experience
• Understanding of healthcare laws and regulations and sales and marketing activities
• CIA, CPA, or other certification in accounting, compliance, or auditing

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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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 $89,622.00 - Maximum $128,800.00, 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