Associate Director

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Associate Director
The candidate will be responsible for designing and managing a US Branded Healthcare Compliance program. Responsibilities will include: regulation of clinical trials, human subject protection and manufacturing; and ensuring compliance with FDA regulations, Pharma Code, government pricing requirements, the federal anti-kickback and false claims statutes, and the Patient Protection and Affordable Care Act. Heavy emphasis on review and approval of advertising and promotional materials. Proactively identify emerging regulatory issues, developments in industry practices and standards and Compliance risk trends; and design appropriate policies and procedures to ensure continuing relevance of the Compliance Program. Determine the potential impact on the business and identify potential areas of compliance risk to ensure policy/procedure and/or enhancements are developed and implemented in order to manage identified risk areas effectively. Develop, initiate, maintain and revise simple, straightforward and practical policies and procedures for the operation of the US Healthcare Compliance Program. Ensure identification, engagement and management of relevant stakeholders across the organization during the development of policies and SOPs. Provide healthcare compliance subject matter expertise in the development of appropriate systems and working tools to support the Compliance Program requirements. Provide relevant input to raise awareness of Compliance related topics. Provide guidance on the Global Compliance Policy/SOP architecture, ensuring sufficient oversight and elaboration of consistent standards at Global level.Prepare Compliance related reports and presentations and other communications for employees and senior management.

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