Associate Director, US Compliance

Role Summary

The Associate Director, US Compliance is responsible for assisting the U.S. Dermatology and Oncology Compliance Leads with the implementation and management of Incyte's U.S. Compliance Program. This role supports efforts to continuously enhance the Compliance program based on the U.S. legal enforcement environment, applying best practices in life sciences compliance. The position requires significant interaction with U.S. Sales and Product Strategy, Legal, Information Technology, Market Access, Medical Affairs, Commercial Operations, and other company departments. The Associate Director, US Compliance reports to the Executive Director, Compliance Lead, U.S. Dermatology.

Responsibilities

• Other duties and special projects as assigned.
• Maintain a current working knowledge of laws, regulations, and industry guidance affecting the corporate-wide compliance program, including federal and state price reporting laws, privacy laws, OIG and DOJ guidelines, PhRMA code, and state marketing compliance laws.
• Develop, lead, and implement continuous improvement activities, including managing documentation and tracking compliance activities.
• Provide guidance to the U.S. Business and integrate compliance controls into existing business practices where applicable.
• Develop and implement tools to empower business stakeholders to make ethical and compliant decisions.
• Support the U.S. Compliance Leads and Compliance Monitoring/Investigations team by conducting field monitoring activities.
• Assist the U.S. Compliance Leads with conducting annual compliance risk assessments, including evaluating results and identifying areas of improvement.
• Collaborate with U.S. Compliance Leads and internal Compliance Monitoring/Investigations team to evaluate and remediate monitoring and investigation findings.
• Partner with the U.S. Compliance Leads and internal Compliance Policy/Training to create and deliver U.S. Business-specific trainings and communications.
• Partner with the U.S. Compliance Leads and internal Compliance Policy/Training to identify policy/guideline needs, develop/enhance policies and guidance documents, and ensure optimal accessibility for the U.S. Business using up-to-date technology.
• Participate in the review and approval process of core U.S. business activities (e.g., Sponsorships, Advisory Boards, Healthcare Professional engagements).
• Participate in routine meetings with U.S. business partners.
• Assist with managing quarterly U.S. Compliance Committees to track compliance efforts, initiatives, and project status updates.
• Develop tools, processes, and reports to support the U.S. business's ownership of Compliance.
• Assist with understanding current and future compliance needs of U.S. business partners.
• Work with the U.S. Compliance Leads to maintain and enhance infrastructure for the U.S. business that supports a company culture of compliance and recognizes that compliance is a collective responsibility of all employees.

Qualifications

• Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
• Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with input from multiple stakeholders. Strong problem solving and risk analysis skills.
• Ability to collaborate and work effectively with cross-functional teams and projects.
• Ability to communicate effectively in both verbal and written form with multiple stakeholders within and outside the company.
• Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry.
• Proven record of accomplishment in U.S. compliance best practices.
• Minimum of 8 years of pharmaceutical/life sciences compliance experience.

Education

• Bachelor's degree required.

Additional Requirements

• Ability to travel up to ~25% including overnights and weekends as needed for business meetings and field monitoring activities.