DIRECTOR, HEALTHCARE COMPLIANCE

The Director, Healthcare Compliance will be the primary Compliance Business Partner supporting our Commercial, Medical Affairs, Patient Services, and Patient Advocacy functions. This broad position will 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.
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) :

• Provide day-to-day oversight and management of Kiniksa’s commercialization efforts.
• Maintain awareness of applicable laws and regulations and keep current with changes that may affect Kiniksa’s Compliance program.
• Develop and maintain relevant policies, procedures, and work instructions related to key area within Compliance to guide the company’s operations.
• Support the development and execution of company’s Compliance training program for new and existing employees.
• Serve as the primary Compliance point of contact for business colleagues and provide risk identification and mitigation support in the development and implementation of business strategies and tactics.
• Provide guidance and compliance oversight on company initiatives, including HCP engagements, speaker programs, sponsorships, grants and other initiatives involving interactions with healthcare professionals, healthcare organizations, patients, and patient advocacy groups.
• Work alongside employees and company leadership to maintain and further develop throughout the organization a strong sense of compliance and ethics, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving.
• Develop and/or identify new work processes, tools or resources that will have broad applicability throughout the organization; contribute ideas for achieving organizational goals.
• Support the business on obtaining access to and training of key compliance tools including Risk Assessments, Vendor Due Diligence, Needs Assessment, Healthcare Professional Tiering and Fair Market Value.
• Assist with the data collection and generation of global transparency reports.
• Assist with drug price reporting for various state and federal reports.
• Assist with internal investigations, as required, to promote a speak-up culture and compliance with all applicable laws and internal policies .

QUALIFICATIONS:

• 8+ years of pharmaceutical compliance, audit and/or other related experience
• B.A./B.S. degree required
• Advanced degree preferred (MBA or JD)
• Certified in Healthcare Compliance (CHC) and/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, government settlements (DPAs and CIAs), and state marketing and price reporting compliance laws.
• Experience with US transparency reporting. Global transparency reporting experience a plus.
• Experience developing and executing audits and monitoring.
• Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with the organizational and regulatory changes.
• Excellent organization, communication, and project management skills with an ability to work in a collaborative, cross-functional environment.
• Candidate must be able to work independently and prioritize multiple demands.
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 25-30%
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA
  Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
  It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability

• Provide day-to-day oversight and management of Kiniksa’s commercialization efforts.
• Maintain awareness of applicable laws and regulations and keep current with changes that may affect Kiniksa’s Compliance program.
• Develop and maintain relevant policies, procedures, and work instructions related to key area within Compliance to guide the company’s operations.
• Support the development and execution of company’s Compliance training program for new and existing employees.
• Serve as the primary Compliance point of contact for business colleagues and provide risk identification and mitigation support in the development and implementation of business strategies and tactics.
• Provide guidance and compliance oversight on company initiatives, including HCP engagements, speaker programs, sponsorships, grants and other initiatives involving interactions with healthcare professionals, healthcare organizations, patients, and patient advocacy groups.
• Work alongside employees and company leadership to maintain and further develop throughout the organization a strong sense of compliance and ethics, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving.
• Develop and/or identify new work processes, tools or resources that will have broad applicability throughout the organization; contribute ideas for achieving organizational goals.
• Support the business on obtaining access to and training of key compliance tools including Risk Assessments, Vendor Due Diligence, Needs Assessment, Healthcare Professional Tiering and Fair Market Value.
• Assist with the data collection and generation of global transparency reports.
• Assist with drug price reporting for various state and federal reports.
• Assist with internal investigations, as required, to promote a speak-up culture and compliance with all applicable laws and internal policies