Job Summary (Primary function)
Essential Functions of the Job (Key responsibilities)
- Assist in the development and communication of annual plans for monitoring activities based on risk assessments, results of current and prior monitoring activities, outcomes from investigations, and other sources including regulatory and enforcement updates and trends.
- Provide assignments to internal and external monitoring resources and conduct live, transactional, and analytical monitoring ensuring fulfillment of annual commitments.
- Develop and maintain dashboards and metrics that accurately report on planned versus actual monitoring status, issues, corrective and preventative action plans and status.
- 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.
- Work closely with the Compliance Business Leads to ensure that monitoring activities continuously align to identified risk areas, adhere to the approved sample selection criteria, and are executed in a consistent manner.
- Manage the compliance monitoring system through accurate configuration and data capture, drafting business requirements, performing user acceptance testing, and assisting in the development of presentations using the system’s dashboards and metrics.
- Assist in the development and execution of compliance analytics that identify trends, patterns or outliers that help drive risk-based actions and decisions.
- Manage the Incyte Compliance Risk Assessment processes within the established timelines. This includes engaging Compliance, Legal and Business stakeholders, preparing reports of Risk Assessment results, and tracking and reporting on mitigation actions.
- Support the Compliance Investigation process through focused transactional monitoring and other assigned research.
- Support additional compliance initiatives and projects.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- BA/BS degree required.
- 5-7 years of compliance, risk management or relevant bio/pharmaceutical industry experience.
- Knowledge of compliance laws, regulations, and industry guidelines.
- Experience independently planning and conducting complex and sensitive monitoring, including data analysis.
- Attention to detail and focus on quality work product.
- Ability to manage and prioritize projects under tight deadlines.
- Excellent written, oral communication, interpersonal, and organizational skills.
- Strong analytical, investigative, and problem-solving skills
- Solution-oriented, team focused and strong technical skills including knowledge and experience using Microsoft applications (Excel, Word, and PowerPoint)
- Ability to travel 25-35%.
- Experience in compliance solutions for data analytics, monitoring and risk management preferred.
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.
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