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Years of Experience
ProfileCompliance Associate The candidate will assists the NA Compliance Officer in the development, implementation and management of the company’s NA compliance program for compliance with applicable laws and regulations in a manner consistent with best practices and applicable law and guidance with particular focus on the operations of the Sales, Marketing, Commercial Operations and Medical Affairs functions in the U.S. Will be managing the company’s compliance with state and federal law requirements and providing of compliance support for state and federal aggregate spend reporting, developing and delivering training, Compliance policies and industry laws, regulations and guidance, assisting in management of investigations as needed, and providing guidance to employees on compliance matters. Assist in the review, revision and development of compliance policies and procedures as needed. Providing guidance and advice to employees on compliance matters, and interactions with all levels within the US and global organization as well as vendors and other internal and external stakeholders. Assists Compliance Officer in maintaining all aspects of the US Compliance Program including compliance policy and procedure development, conducting and maintaining compliance training presentations and records, monitoring of compliance hotline, field and internal monitoring and auditing activities. Manages the company’s compliance with state and federal aggregate spend reporting and disclosure laws. Works closely with and provides compliance support to business units responsible for aggregate spend data (e.g. global compliance, medical, finance, IT). Develops and delivers training in compliance risk areas and regarding policies. Develops and implements Compliance communications. Designs and performs or coordinates compliance monitoring activities. Assists Compliance Officer in risk assessments and reviews of compliance risk areas to determine need for improvement often in consultation and coordination with internal and external audit groups. Prepares reports of compliance activities and metrics. Provides guidance and expertise to local and global business partners on US compliance process issues. Participates in investigations of potential compliance issues in accordance with company policy. Works closely with Legal department to ensure appropriate legal risk management. Works closely with cross-functional teams assessing proposed programs and activities.
Qualification and Experience
The candidate must have a Bachelor’s degree from an accredited institution; post-graduate degree or law degree a plus. Should have previous experience of working in or for the pharmaceutical/biotechnology industry, some of that experience involving the implementation of compliance programs, and an understanding of US pharmaceutical and other regulations, sales, marketing and medical practices. Must have strong interpersonal skills, a flexible, collaborative and team-oriented approach to problem-solving and an ability to work in a fast-paced, rapidly changing environment. Should demonstrate knowledge and understanding of pharmaceutical compliance issues.
Req Id: 4701