Senior Associate, Healthcare Law Compliance Monitoring

Otsuka Pharmaceutical Co., Ltd.Princeton, NJ
$89,622 - $128,800Hybrid

About The Position

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.

Requirements

  • 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

Nice To Haves

  • 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

Responsibilities

  • 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.

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
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