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Working knowledge of the industry regulations, standards and laws related to information security and data privacy, including HIPAA, GDPR, NIST. 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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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. The Senior Manager of Ethics & Compliance will provide leadership and oversight of Civica's ethics & compliance program and policies.
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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. 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. 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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Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. BS or BA degree with at least 10 years of relevant experience.
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Abides by the Health Insurance Portability and Accountability (HIPAA) privacy and security regulations regarding all aspects of Protected Health Information (PHI). demonstrated leadership skills in decision making, process improvement, problem solving, coaching to performance expectations, investigations, staffing to acuity/volume metrics, achieving measurable improvements in patient experience, patient flow/throughput, staff engagement, and improving physician relations.
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Regular monitoring, analysis, audits, and investigations of IT infrastructure, use, and performance to optimize security, productivity, polices, and Key Performance Indicators (KPIs) is required, as is oversight of key contracts, such as ISP, MSP, and cloud vendors (Microsoft, Salesforce, et cetera.
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CISSP, CISA, HCISPP, CHC, CHPC, CHSP, CISM or other relevant certifications in information security or privacy preferredExperience in developing and accessing technical and process-based controls, managing risk assessments/investigations, and working with organization management to integrate controls into the scope of existing business practices preferred.
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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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To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace. The facility is currently in late-stage construction and hiring for the site is well-underway.
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