Sr. Manager Of Ethics & Compliance

About Civica

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. 

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. 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. 

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. The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

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. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Job Description:

The Senior Manager of Ethics & Compliance will provide leadership and oversight of Civica’s Ethics & Compliance program and policies. A key function of the position will involve continued development, maintenance, monitoring, and execution of the compliance program and corporate policies at Civica, Inc.

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.

Essential Duties and Responsibilities:

• 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.
• Annual PPSA Transparency data collection and reporting to CMS.
• 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
• Monitor legislative landscapes, compliance trends, and recent enforcement activities by relevant government authorities to provide updates to management.
• 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.
• 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.
• 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. Participate in the due diligence and/or qualification of/by third parties.
• Other duties as assigned by the Chief Ethics & Compliance Officer. 

Basic Qualifications and Capabilities:

• BS or BA degree with at least 10 years of relevant experience.
• Certified in Healthcare Compliance (CHC) or similar.
• Working knowledge of PRhRMA Code, Federal Anti-Kickback Law, False Claims Act, Drug Takeback Programs, and knowledge of relevant pharma Federal and State Laws.
• Working knowledge of the industry regulations, standards and laws related to information security and data privacy, including HIPAA, GDPR, NIST.
• Competent knowledge of and ability to use Microsoft Office suite.
• Ability to follow company procedures, work instructions, and policies.
• Ability to process, synthesize and summarize complex issues.
• Excellent judgment, and analytical, problem-solving skills.
• Excellent attention to detail and organizational skills
• Ability to multi-task and prioritize work tasks with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.