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This position will report to the Chief Ethics & Compliance Officer and work cross-functionally with members of the Commercial, Legal, Manufacturing, Finance, Human Resources, Regulatory, Quality, Research and Development Teams to promote awareness and understanding of positive ethical principles and ensure continuous suitability and alignment of compliance program framework and controls with relevant laws and Civica's goals.
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Other duties as assigned by the Chief Ethics & Compliance Officer. With support from Legal department, lead internal investigations related to the compliance program and if required, implementation of applicable corrective and preventative measures and reporting to relevant government agencies.
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The Senior Manager of Ethics & Compliance will provide leadership and oversight of Civica's ethics & compliance program and policies. Working knowledge of the industry regulations, standards and laws related to information security and data privacy, including HIPAA, GDPR, NIST.
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Certified in Healthcare Compliance (CHC) or similar. Monitor legislative landscapes, compliance trends, and recent enforcement activities by relevant government authorities to provide updates to management.
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Implement and oversee company-wide ethics and compliance program, policies, and controls. Develop and evolve relevant and robust policies and other guidance documents to ensure compliance with applicable laws and regulations, and industry standards.
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Proactively drive culture of integrity, ethical behavior, and compliance by drafting and disseminating written materials and training that are aimed at increasing stakeholders' awareness and understating of relevant regulatory requirements and industry standards.
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Conduct compliance risk assessments and create a workplan to coordinate implementation of necessary mitigation actions, aligned with evolving regulatory requirements, industry standards, and business initiatives and strategies.
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Serve as an internal subject matter expert and provide strategic advice to internal stakeholders and management on matters relating to compliance and ethics, such as: Healthcare compliance Cybersecurity compliance Privacy Government contracts DEA Business ethics.
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A key function of the position will involve continued development, maintenance, monitoring, and execution of the compliance program and corporate policies at Civica, Inc. Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
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Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines. Annual PPSA Transparency data collection and reporting to CMS.
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Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Participate in the due diligence and/or qualification of/by third parties. Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines.
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BS or BA degree with at least 10 years of relevant experience. To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
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The facility is currently in late-stage construction and hiring for the site is well-underway. Ability to multi-task and prioritize work tasks with minimal supervision. To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine.
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Serve as an internal subject matter expert and provide strategic advice to internal stakeholders and management on matters relating to compliance and ethics, such as:Healthcare compliance.
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Investigate information leaving the organization with appropriate leadership (i.e. Manager, ECO, HR, Legal) Coordinate with HR Director, Facility Privacy Official and Ethics & Compliance Officer to ensure that sanctions related to IPS issues are applied appropriately and consistently.
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