layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Director, Healthcare Compliance at Kiniksa Pharmaceuticals | LAYIQ

including, but not limited to ): Define and lead the Compliance & Ethics strategy for the Commercial organization, as well as other key business areas, aligning compliance priorities with Company growth, product lifecycle, and market expansion.
Serve as the accountable Compliance & Ethics business partner for Commercial, as well as Medical Affairs, Patient Services, and Patient Advocacy.
Represent Compliance & Ethics in cross-functional leadership discussions, proactively embedding compliance into business planning.
Design and help build scalable compliance processes and procedures to support future product launches and geographic expansion.
Proactively identify, assess, and advise on mitigation of compliance risks across external-facing business activities.
Provide clear, actionable guidance on complex topics, including: Engagements with Healthcare Professionals (HCPs), sponsorships, grants, and charitable contributions, patient support programs, patient advocacy group interactions, market access and emerging commercialization models
Partner with Commercial leadership to design processes and procedures that enable compliance.
Oversee the development, implementation, and effectiveness of Compliance & Ethics policies, standards, and governance for Commercial, as well as other external-facing business areas.
Provide input into the development and implementation of a risk-based monitoring and auditing program, leveraging data and analytics.
Ensure healthcare compliance requirements are addressed in other program activities, including but not limited to: Risk assessments, third-party due diligence, fair market value, and tiering of HCPs, and needs assessments
Act as a visible and trusted compliance leader, fostering a “speak-up” culture.
Provide guidance on key regulations, standards, and industry codes, including but not limited to: Anti-kickback laws, False Claims Act, Fraud & abuse laws, U.S. Department of Justice (DOJ) and U.S. Health & Human Services Office of Inspector General (OIG) Compliance Program Guidance, PhRMA Code
Standout Skills for Impact: Maintain deep expertise in applicable laws and monitor external compliance developments within the pharmaceutical industry
Drive innovation in compliance operations through technology, automation, and process improvement
Champion a culture of transparency, ethical decision-making and accountability across Commercial, as well as other key external-facing business areas
Together with other Compliance & Ethics team members, lead the development of role-specific, risk-based training and awareness programs that drive behavior change

Senior Director, Healthcare Compliance

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Equal opportunity and accommodations

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