Jobs · Legal · Massachusetts

Associate Director, Compliance & Ethics

Kiniksa Pharmaceuticals · Lexington, MA · 3 wk ago
Legal$170k–$190k/yrFull-time

Responsibilities

  • Drive the development and execution of the Company’s annual Compliance & Ethics monitoring and auditing plan, including updating and revising based on new and/or emerging compliance risks.
  • Oversee monitoring and auditing activities by Compliance & Ethics team (including both live and desktop activities) to ensure compliance with applicable laws, regulations, and Company policies.
  • Track and report on progress of monitoring and auditing activities, including drafting reports, analyzing data, communicating results and supporting data analytics throughout multiple levels of the organization.
  • Act as subject matter expert on transparency, aggregate-spend and reporting requirements.
  • Facilitate data collection and generation of transparency reports and subsequent reporting to applicable authorities.
  • Lead the development, implementation, and continuous improvement of policies, processes, work instructions and controls, governing spend capture, data validation and reporting.
  • Collaborate closely with internal and external stakeholders to track and ensure complete, accurate and timely submissions under applicable laws and regulations.
  • Maintain understanding of applicable transparency and reporting laws, regulations and industry codes.
  • Support compliance and enterprise risk assessments, conduct root cause analyses, risk mitigation planning and execution, and regular risk reviews to ensure effectiveness of Kiniksa’s Compliance & Ethics program and Enterprise Risk Management (ERM) program.
  • Track and report on risk assessment results, including drafting reports, analyzing data and communicating results to Compliance & Ethics program key stakeholders.
  • Provide leadership in helping Kiniksa maintain and further develop a strong culture of compliance and ethics, including driving personal accountability for compliance and ethics.
  • Develop and/or identify new work processes, tools or resources that will have broad applicability throughout the organization; contribute ideas for achieving organizational goals.

Qualifications and Experience

  • B.A./B.S. degree or equivalent required.
  • 8+ years in compliance, ethics, audit and/or related roles within biotech/pharma.
  • Strong experience with transparency and aggregate spend reporting.
  • Experience developing and executing compliance and ethics monitoring and auditing plans.
  • Strong data analysis and reporting skills.
  • Knowledge of applicable healthcare compliance laws, regulations and industry codes.
  • Demonstrated attention to detail and high-quality work product.
  • Ability to prioritize and work effectively in a fast-paced environment.
  • Proficient with Microsoft Office and reporting tools (e.g., Tableau, Smartsheet, Cognos Report, Query Studio).
  • Commitment to high ethical and compliance standards.
  • Ability to travel up to 20%.

Similar jobs