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 Monitoring, Risk and Investigations function. The role is located in Incyte's global headquarters and is responsible for developing, managing and conducting Incyte's Compliance Monitoring program, leading and enhancing Incyte's Compliance Risk Assessment process and leading Incyte's Compliance Investigations and related systems and reporting.
Essential Functions of the Job (Key responsibilities)
Develop annual plans for monitoring activities based on risk assessments, results of current and prior audit and monitoring activities, outcomes from investigations, and other sources including regulatory and enforcement trends.
Develop and manage monitoring tools and processes.
Lead and manage data, transaction, and live monitoring activities.
Increase utilization of data analytics in monitoring approach and execution
Organize and evaluate facts and evidence and draw sound conclusions in relation to monitoring activities and processes.
Oversee maintenance of monitoring files, evidence, and other records.
Prepare timely, accurate, and complete reports with corrective action recommendations and follow-through with key stakeholders for implementation.
Develop, prepare, and manage periodic reporting of results to senior management.
Conduct analysis to understand factors contributing to potential policy violations, develop recommendations and assist with the design of controls and standards for identified gaps in monitoring activities.
Assist in the identification of compliance program enhancements, including training needs, policy updates and other improvements.
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.
12+ 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... For full info follow application link.
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