Compliance Director

1 week ago

Lexington, Kentucky, United States Kiniksa Pharmaceuticals Full time
Job Title: Associate Director, Compliance

Reporting to the Senior Director, Compliance, the Associate Director, Compliance will play a vital role in enhancing Kiniksa's Compliance program.

This position will provide a broad range of compliance support and collaborate closely with internal and external business partners to implement, maintain, and improve Kiniksa's compliant and ethical practices and behaviors.

The Associate Director, Compliance will be responsible for executing key elements of Kiniksa's auditing and monitoring program and ensuring compliance with US and global transparency requirements.

Responsibilities:
  • Identify new work processes, tools, or resources that will have broad applicability throughout the organization and assist with the implementation of Compliance systems and processes.
  • Provide training to internal and external organizational clients on a broad range of topics, including anti-bribery, FDA regulations, transparency reporting, and company policies.
  • Assist in the development and maintenance of relevant Standard Operating Procedures, work instructions, and guidance documents related to key areas within Compliance.
  • Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities.
  • Maintain an understanding of disclosure laws, regulations, and applicable industry codes.
  • Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations, and company policies.
  • Review Medical and Commercial documentation to ensure compliance with company SOPs and policies.
  • Partner with cross-functional colleagues to address detected noncompliance, including corrective actions when needed.
Qualifications:
  • Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 7+ years in compliance, audit, and/or other related experience required.
  • Certified in Healthcare Compliance (CHC) or Project Management Professional (PMP) a plus.
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry, including global aggregate spend and other reporting/sunshine laws, fraud and abuse, and anti-kickback statutes, OIG, and PhRMA guidelines, and state marketing and price reporting compliance laws.
  • Experience with US and global transparency reporting.
  • Experience developing and executing audits and monitoring.
  • Strong operational and project management skills required.
  • Excellent organization, communication, and presentation skills.
  • Candidate must have strong team orientation and problem-solving skills.
  • Candidate must be able to work independently and prioritize multiple demands.

This position requires 35-40% travel. Salary is commensurate with experience. Kiniksa Benefits Summary - USA

All Kiniksa new hires whose roles require them to enter Kiniksa's physical offices will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.

Requests for accommodation will be considered on a case-by-case basis, and Kiniksa will consider, among other things, whether a proposed accommodation would create an undue hardship.

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