Associate Director, Compliance

Reporting to the Senior Director, Compliance, the Associate Director, Compliance will serve an important role in Kiniksa's continued enhancement of its Compliance program. This position will provide a broad range of compliance support and work to assist in the implementation, maintenance, and continued improvement of Kiniksa's compliant and ethical practices and behaviors through close collaboration with internal and external business partners. The Associate Director, Compliance will also have primary responsibility for executing key elements of Kiniksa's auditing and monitoring program and ensuring compliance with US and global transparency requirements.This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):

General

Help identify new work processes, tools or resources that will have broad applicability throughout the organization and assist with the implementation of Compliance systems and processesProvide training to internal and external organizational clients on a broad range of topics including anti-bribery, FDA regulations, transparency reporting and company policiesAssist in the development and maintenance of relevant Standard Operating Procedures, work instructions, and guidance documents related to key areas within ComplianceTransparency Reporting

Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authoritiesMaintains understanding of disclosure laws, regulations and applicable industry codesAuditing & Monitoring

Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policiesReview of Medical and Commercial documentation to ensure compliance with company SOPs and policiesPartner with cross-functional colleagues to address detected noncompliance, including corrective actions when neededQualifications:

Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 7+ years in compliance, audit and/or other related experience required. Pharmaceutical experience requiredCertified in Healthcare Compliance (CHC) or Project Management Professional (PMP) a plusKnowledge 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 lawsExperience with US and global transparency reportingExperience developing and executing audits and monitoringStrong operational and project management skills requiredExcellent organization, communication and presentation skills. Candidate must have strong team orientation and problem-solving skillsCandidate must be able to work independently and prioritize multiple demandsThis position requires 35-40% travelSalary is commensurate with experienceKiniksa 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.