Associate Director, US Compliance

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)

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 includes supporting efforts to continuously enhance Incyte's Compliance program based on the legal enforcement environment in the U.S. through application of best practices in the life sciences Compliance space. This role 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 will report to the Executive Director, Compliance Lead, U.S. Dermatology.

Essential Functions of the Job (Key responsibilities)

• Other duties and special projects as assigned.
• Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal 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 the scope of 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 assist with evaluating and remediating 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 the most up-to-date technology.
• Participate in the review and approval process of certain core U.S. business activities (e.g., Sponsorships, Advisory Boards, Healthcare Professional engagements, etc.).
• Participate in routine meetings with U.S. business partners.
• Assist with managing quarterly U.S. Compliance Committees to track compliance efforts and 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 company employees.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• 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 the input of appropriate 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 the areas of U.S. compliance best practices.
• Minimum of 8 years of pharmaceutical/life sciences compliance experience.
• Bachelor's degree required.
• Ability to travel up to ~25% including overnights and weekends as needed for business meetings and field monitoring activities.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.