The Senior Director Compliance, assists the Senior Vice President, Chief Compliance Officer (CCO) in developing, implementing and maintaining an effective Corporate Compliance Program that:
-Supports and promotes a company-wide culture of ethics and compliance
-Meets or exceeds applicable regulatory guidance for compliance programs, including the
standards within the OIG Guidelines for an Effective Compliance Program, Department of Justice
guidance, and the U.S. Federal Sentencing Guidelines
-Ensures the company's compliance with all applicable federal and state health care laws and
regulations, and industry codes of conduct
Manages elements of the Avanir Compliance Program, including but not limited to:
Managing the company’s compliance infrastructure and oversight controls and mechanisms.
Overseeing the company’s internal and external compliance monitoring and auditing, including external reporting as necessary.
Developing and delivering compliance training at company and departmental meetings.
Assisting the CCO in preparing and presenting reports and dashboards to the Compliance Committee and the Board of Directors developing, revising, updating and maintaining compliance policies, procedures and instructions, and collaborates with other departments of the company in addressing their policies, etc. relating to or impacting the company's compliance program.
Assisting the CCO in preparing the annual compliance work plan based upon a comprehensive, annual compliance risk assessment of relevant functional areas of the company.
Leading or supporting the implementation of systems (both IT systems and processes) that enable efficient, consistent and compliant execution of business activities.
Possesses and maintains an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct and developments, and best practices applicable to the company's policies, practices or operations, including but not limited to the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, PDMA, AMA, and industry guidance documents, regulations regarding the promotion of marketed products, clinical trial regulations, and the False Claims Act and anti-kickback statutes.
Managing team members and projects to ensure inter and intra department coordination .
QUALIFICATIONS
Minimum of ten (10) years’ compliance experience in the pharmaceutical or device industry.
Significant experience managing compliance within the context of a Corporate Integrity Agreement highly desirable
3+ Years Experience in people management
3+ Years Experience in managing budgets
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