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Cangene Corporation
155 Innovation Drive
Winnipeg MB Canada
R3T 5Y3
Fax: (204) 275-4021
Email: hr@cangene.com
| Department Of Other | |
| Title | Corporate Risk & Compliance Officer |
| Description | The Corporate Risk & Compliance Officer (CRCO) reports to the Chief Financial Officer and assists with the planning, development, and execution of corporate risk management & compliance strategies and objectives. The CRCO is responsible for risk management & compliance policy, committee coordination, training and education, lines of communication, monitoring and auditing, enforcement and investigations, corrective and disciplinary action. The CRCO will partner with internal business leaders and department managers to increase the awareness of the company’s Enterprise Risk Management and Corporate Compliance Programs (ERM/CCP) and their obligations thereunder. The position calls for significant interaction with business colleagues in Commercial Operations, Regulatory Affairs, Medical Affairs, Legal, Human Resources, Internal Audit, Finance, IT and others as required. |
| Accountabilities | - Develop and implement initial policies and procedures, as well as continue to modify and improve the ERM and CCP programs, and related policies and procedures as required to meet government, industry, and the company’s compliance requirements with an emphasis on the required elements of a ERM/ CCP as outlined in, but not limited to, the COSO ERM framework and the OIG Compliance Program Guidance for Pharmaceutical Manufacturers; - Organize and coordinate the activities of a Corporate Risk & Compliance Committee, consisting of representatives of the primary stakeholder functions, to oversee the ongoing direction and operation of the ERM and CCP programs; - Support management processes to set objectives, including strategic, operational, reporting and compliance objectives, that align with the company’s mission and are consistent with risk tolerance; - Conduct risk and opportunity assessments, recommend risk responses and ensure control activities are in place to effectively carry out responses and manage risks; - Develop, maintain and evolve compliance and risk training curriculum, assisting with or delivering compliance and risk related training to all necessary management and staff members with emphasis on sales force personnel, independent contractors, agents, and other colleagues involved in sales and marketing, seeking to ensure all affected employees and management understand risks relating to our objectives and comply with pertinent federal and state standards; - Identify and help resolve weaknesses in the compliance program or systemic patterns of noncompliance and monitor solutions for effectiveness; - Coordinate and conduct internal risk management and compliance reviews and monitor activities focusing efforts on financial compliance (ICFR), commercial compliance (sales and marketing), government contracting compliance (not GxP compliance) and compliance with the company’s Code of Business Ethics; - Monitor the company's Whistleblower Hotline/Helpline and coordinate internal investigations responding to reports of problems or suspected violations; - Communicate and report on a regular basis to the Board of Directors, CEO/President, and Executive Management, Staff and other Stakeholders on risk and compliance matters. |
| Management Accountabilities | |
| Qualifications | - A University degree, preferably in law, combined with a Bachelor of Science degree and/or sales and marketing accreditation. - Minimum of five (5) years bio/pharmaceutical compliance and/or regulatory experience in an in-house, consulting or advisory capacity. Experience in reporting/presenting to senior management regarding risk and compliance related matters is desired. - Knowledge and understanding of enterprise risk management and compliance principles and best practices affecting the bio/pharmaceutical industry, including the legal and regulatory framework. - Familiarity with operational, financial, quality assurance, and human resource procedures a must as is the ability to self direct, work independently and communicate persuasively. |
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ISO 9001- 2008 Certified