Director, Corporate Compliance Horizon Pharma
THIS JOB HAS EXPIRED Description
The Director, Corporate Compliance assists the Chief Compliance Officer in the development, implementation and management of the company?s compliance program for compliance with applicable laws and regulations in a manner consistent with the best practices and applicable law and guidance. With particular focus on the operations of the Sales, Marketing, Commercial Operations and Medical Affairs functions, responsibilities include managing the company?s compliance with state requirements and providing of compliance support to the aggregate spend systems, developing and delivering training on Horizon Pharma Compliance policies and industry laws, regulations and guidance, managing investigations, managing and participating in review processes, and providing guidance to employees on compliance and ethics matters. The Director, Corporate Compliance will have a significant role in assisting in the development of compliance policy. The Director, Corporate Compliance will be expected to be able to bring independent judgment in the conduct of investigations, the provision of guidance and advice to employees on compliance and ethics matters, and interactions with senior management and vendors and other internal and external stakeholders. The position helps to ensure the Company, Board of Directors, management and employees are in compliance with the rules and regulations of regulatory agencies, that company policies and procedures are being followed, and that behavior in the organization meets the company?s Code of Business Conduct and Ethics and supporting policies and procedures (collectively the ?Code of Conduct?).
The Corporate Compliance Office exists:
As a channel of communication to receive and direct compliance issues to appropriate resources for investigation and resolution, and
As a final internal resource with which concerned parties may communicate after other formal channels and resources have been exhausted.
Additionally, the Director of Corporate Compliance acts as staff to the Chief Compliance Officer (CCO) by monitoring and reporting results of the compliance/ethics efforts of the company and in providing guidance for the CCO, Board and senior management team on matters relating to compliance.
Develops and periodically reviews and updates Code of Conduct to ensure continuing currency and relevance in providing guidance to management and employees.
Manages the company?s compliance with state and federal aggregate spend reporting and disclosure laws requiring specific compliance program elements.
Works closely with, and provides compliance support related to the aggregate spend system.
Develops and delivers training in compliance risk areas and regarding Horizon Pharma policies.
Develops and implements Compliance communications.
Designs, performs and coordinates compliance monitoring activities.
Develops and executes risk assessments and reviews of compliance risk areas to determine need for improvement.
Prepares reports of compliance activities and metrics.
Counsels and provides leadership with business partners on compliance process issues
Undertakes 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.
Collaborates with other departments (e.g., Commercial Operations, Finance, HR, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution. Consults with internal and external counsel as needed to resolve difficult legal compliance issues.
Works under direction from the CCO to respond to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
Provides direction and management of the compliance Hotline.
Works with the Human Resources Department and others as appropriate to develop an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers.
Qualifications and Skills Required:
Experience interfacing with FDA preferred; OPDP/DDMAC/OIG is essential.
Expert working knowledge of regulations and their implementation and specific experience in the area of advertising and promotion and the ability to support multiple commercial products.
Demonstrates ability to identify emerging issues and initiates actions to recommend solutions, including in areas of ambiguity.
Expert compliance and pharmaceutical industry knowledge with proficiency in representing/interpreting the strategic business objectives of the company.
A Bachelor?s degree required, MBA or JD may be a plus
A minimum of 10 years? experience in a healthcare organization, to include demonstrated leadership.
Familiarity with operational, financial, quality assurance, and human resources procedures and regulations.
Proficient in Microsoft Office
Professional, proactive demeanor
Strong Interpersonal skills
Excellent written and verbal communication skills
Essential Core Competencies:
Drive for Results
Dealing with Ambiguity
||Deerfield, IL |
THIS JOB HAS EXPIRED