at Incyte Corporation in Wilmington, Delaware, United States
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)
This position reports directly to Incyte's Chief Compliance Officer and is responsible for management and oversight of Incyte's Global Risk, Monitoring and Investigations function. The role is located in Incyte's global headquarters and is responsible for leading, implementing and enhancing Incyte's Compliance Risk Assessment and Monitoring programs. The role is also responsible for overseeing the operations of Incyte's Compliance Investigations function including maintenance of the Compliance helpline, the Navex investigations tracking system and reporting on investigation metrics.
Essential Functions of the Job (Key responsibilities)
Develop annual plans for monitoring activities across Incyte's global business based on risk assessments, results of current and prior audit and monitoring activities, outcomes from investigations, and other sources including regulatory and enforcement trends. Plans should be appropriately tailored to individual markets and take into consideration available resources.
Develop and manage monitoring systems and processes, and evaluate opportunities for enhanced automation of current systems.
Lead and manage the execution of data, transaction, and live monitoring activities
Work closely with Regional and Global Compliance leads to ensure that monitoring plans, activities and dashboards address business needs and risk profiles
Increase utilization of data analytics in monitoring approach and execution
Organize and evaluate facts and evidence to draw sound conclusions in relation to monitoring
Develop, manage and maintain Incyte's internal Compliance Risk Assessment and Product Risk Assessment processes.
Engage relevant business and legal stakeholders to conduct ongoing risk evaluations.
Prepare reports for business stakeholders outlining Risk Assessment results.
Assist in development of annual Compliance planning/objectives based upon risk assessment results.
Lead/Manage Risk Oversight Council by planning quarterly meetings, delivering updates to applicable team members, leading meeting with Chief Compliance Officer, and developing reports and deliverables to the Executive Team on behalf of the Risk Oversight Council.
Lead, Manage, and/or oversee Risk Management sub-groups that manage high risk activities or emerging risks (when applicable).
Manage Incyte's Compliance Investigations function by leading data gathering, interviews, and other fact-finding activities to understand the allegation or issue.
Manage Investigations System by performing timely updates to cases in the system and ensuring each case is properly documented.
Coordinate with applicable Incyte departments (including HR) to review evidence for each investigation and developing and documenting Compliance recommendation for each investigation.
Prepare reports summarizing Investigations activity for Incyte management, including Global Compliance Committee.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BA/BS degree required; Advanced Degree preferred.
10+ years of relevant experience preferably in the bio/pharmaceutical industry
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws, the Foreign Corrupt Practices Act, the UK Bribery Act, and other anti-bribery laws
Experience independently planning, conducting, and overseeing complex auditing, monitoring, risk and/or investigation activities
High level of discretion and ability to maintain confidentiality of sensitive company matters
Strong detail orientation and focus on quality work product
Ability to manage and prioritize projects under tight deadlines
Strong ability to effectively partner with internal and external stakeholders
Strong written, oral communication,... For full info follow application link.
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