The Associate Director, Healthcare Compliance Counsel will be responsible for designing and managing a US Branded Healthcare Compliance program. The responsibilities will include, regulation of clinical trials, human subject protection and manufacturing; and ensuring compliance with FDA regulations, PhRMA 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.
- JD degree from an accredited law school is required. At least 5 years of related professional experience in the Pharmaceutical Industry.
- Knowledge of healthcare law, including general principles of Medicare reimbursement programs, anti-fraud statutes is also required.
- Must have knowledge of Sunshine Act/Open Payments requirements.
- Ability to interact well with people from various levels within the organization (including senior management) and across functional units (including commercial, clinical corporate and R&D) is required.