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- Durham, NC
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VP Chief Compliance Officer
ExecuNet • Durham, NC
Posted 2 months ago
What we do
Company is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.
How you’ll contribute
The VP, Chief Compliance Officer is responsible for the development, implementation, maintenance and continual improvement of the company-wide Compliance Program and monitoring and promoting compliance at Company in accordance with Company’ Code of Conduct and Ethics, Comprehensive Compliance Policies, and applicable international, federal and state laws and regulations.
- Develop, oversee, and monitor the effectiveness of the Company Compliance Program; managing the department budget and coordinating with vendors, third parties, and others to develop and maintain a robust and effective function
- Ensure the Company meets its obligation under the Corporate Integrity Agreement (CIA)
- Report on the status of Company’ Compliance Program on a regular basis to Company’ Compliance Committee and the Board of Directors
- Serve as Chair of Company’ Compliance Committee
- Provide strategic direction to and oversight of a team of compliance professionals
- Modify the Compliance Program, as appropriate, to reflect changes, clarifications or updates in applicable laws, regulations and policies; and changes in the nature or scope of Company’ business (including, but not limited to, new or expanded lines of business, new or expanded geographical presence, and new or expanded contractual obligations)
- Oversee the annual Risk Assessment and Mitigation Process and apprise senior management and the Compliance Committee of the results
- Develop annual communication, training, monitoring and auditing plans and oversee the execution of such plans
- Oversee the creation of new policies and procedures and the annual review of existing policies and procedures
- Oversee the investigation of suspected violations of applicable laws, regulations or policies and recommend corrective action (including disciplinary action) where appropriate
- Interact and collaborate with all levels of organization and across multiple functions, including Company’ Chairman & CEO, other executive officers, the Vice Chair and Lead Independent Director of the Board of Directors, Company Legal Counsel, and all other senior management
- Ensure any compliance concerns are documented and acted upon in a timely and appropriate manner
- Perform other duties as assigned
For this role you will need
- BA/BS degree and 15+ years of experience in the biotechnology and pharmaceutical industry, with progressive experience and leadership within corporate compliance roles.
- Familiarity with operational, financial, quality assurance, and human resource procedures and regulations.
- Strong interpersonal and communication with clear, concise and persuasive writing and presentation skills
- In-depth understanding of the pharmaceutical industry with expertise in the body of laws and regulations impacting pharmaceutical companies
- Proactive identification, leadership, and resolution of problems or issues
- Ability to influence and enlist support in achievement of objectives
- Ability to work in a fast-paced environment while demonstrating flexibility, commitment to team work, and a willingness to adapt assignments to meet the company’s needs
- Proficiency with MS Office Suite (Word, Excel, Outlook, PowerPoint) and with working in a Mac and/or PC/Windows environment
- Proficiency with MS Project, Adobe Acrobat, Visio, and excellent data entry skills
- Ability to travel up to 40% as needed
- MS degree or JD
- Experience in a corporate compliance leadership role with a company under a CIA
- Membership in and/or certification by Health Care Compliance Association