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%.