Location: Lexington,MA, USA
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 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
Transparency Reporting
* Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities
* Maintains understanding of disclosure laws, regulations and applicable industry codes
Auditing & Monitoring
* Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policies
* Review of 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. Pharmaceutical 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.