Ethics & Compliance Manager North America, CSL Vifor

Location

King of Prussia, PA | United States

Job description

The Opportunity:

Reporting to the Regional Lead, Regional Ethics & Compliance Officer, NA , as the Ethics & Compliance Manager North America, CSL Vifor , you will be a key member of the North America (NA) Ethics & Compliance (E&C) team with a primary focus on CSL Vifor, works closely with internal business clients and contributes to the success of the NA E&C function to support the Company to achieve its compliance obligations, purpose, and strategic goals aligned to the NA and Global E&C strategic roadmap. You will support CSL Vifor’s core elements of an effective compliance program and the progression and advancement of CSL’s NA Ethics & Compliance program as part of an enterprise-wide Ethics & Compliance program approach. This role primarily supports CSL Vifor NA in meeting its compliance objectives and obligations and collaborates with the CSL Vifor NA team to foster the company’s Ethics & Compliance program (and culture) to ensure compliance with policy, statutory and regulatory mandates. You will also support the operational implementation of projects, processes and tools established by the NA Regional Ethics & Compliance Officer. This is a hybrid role, which requires some onsite work.  #LI-hybrid​

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The Role:

• The incumbent is responsible for executing programs, priorities, and operations as established by the NA Regional Ethics & Compliance Officer. The role is responsible for implementing short to medium term activities to ensure that the CSL Vifor NA organization is risk aware, compliant and change ready.
• Acts as the CSL Vifor NA Ethics & Compliance business partner and compliance advisor, providing counsel, specialist input and expertise, recognized as the Subject Matter Expert (SME) in compliance. The incumbent supports compliance risk assessments and supports the CSL Vifor NA business in developing controls to mitigate issues through the issues/risks management process.  Also supports setting the compliance risk assessment cadence for CSL Vifor NA.
• Completes the maintenance of obligations to controls mapping for the NA region including CSL Vifor NA, CSL Behring NA and CSL Seqirus NA.
• Responsible for implementation of internal and external compliance standards to business practices, programs, and processes in CSL Vifor NA. Provides ongoing compliance risk advice and guidance to CSL Vifor NA regarding application of internal and external (code, regulatory, legal, other) standards to business practices and programs and impacts from regulatory and business changes. Ensures consistent oversight and Ethics & Compliance standards.
• Implements plans to ensure local CSL Vifor NA policies and internal obligations are met in accordance with global/ NA region direction or changes in local regulations, business conditions or from events that may impact Ethics and Compliance requirements.
• Delivers the NA compliance training program and works with the CSL Vifor NA business to implement. The incumbent will support development of Ethics & Compliance content for compliance training programs for NA, liaise with Legal Operations and Services to develop training communications and materials for impacted stakeholders, and ensure adequate visibility of compliance program initiatives as applicable.
• Support the NA Regional Ethics & Compliance officer in responding to alleged violations of rules, regulations, policies, procedures, and the CSL Code of Responsible Business Practice in line with the Global Speak Up policy & procedures in accordance with the global investigation handbook.
• Support the NA Regional Ethics & Compliance Officer with compliance risk management meetings for CSL Vifor NA by staying current on development and treatment action plans for top compliance risks for CSL Vifor NA and identifying potential areas of compliance vulnerability and risk. The incumbent will support the business to develop/implement corrective action plans for resolution of problematic issues and provides general guidance on how to avoid or deal with similar situations in the future.
• Support the Enterprise Risk, Ethics & Compliance (EREC) Monitoring & Assurance team as needed for monitoring activities along with ensuring the business implements corrective actions as needed.
• Support the NA Regional Ethics & Compliance officer as directed to monitor regulatory activity and legislation in NA to changes in business conditions or events that may impact Ethics and Compliance requirements.
• Proactively engage and partner with E&C, EREC, Legal and Business colleagues.

Your Skills and Experience:

• Bachelor’s degree in Business, Risk Management or Law preferred
• Certification in compliance, audit, risk management, or a related function preferred.
• 4+ years of progressive experience in health care, regulatory, ethics, compliance, privacy audit, or risk management experience; or any combination of education and experience, which would provide an equivalent background.
• Demonstrable compliance experience, ideally in a multinational company; pharmaceutical, life sciences or manufacturing background preferred.
• Thorough understanding of the FDA, OIG, PhRMA Code, and other federal, state/provincial legal rules and regulations, and compliance guidance, relevant to the pharmaceutical industry
• Working knowledge of pharmaceutical compliance programs and legal environment
• Practical experience of implementing compliance projects
• High degree of professional ethics, integrity, and excellent judgment
• Self-motivated, results oriented self-starter with the ability to influence others to accept practices and approaches, and build strong networks throughout the organization.
• Strong interpersonal and communication skills, a flexible, collaborative, and team-oriented approach to problem-solving and an ability to work in a fast-paced, rapidly changing environment.
• Exceptional attention to detail and commitment to project ownership, accuracy, and completion on a timely basis
• Strong verbal, written and communication skills and interpersonal skills with the ability to effectively listen to and communicate with various levels of the company.
• Ability to analyze data, identify trends, summarize information, and analyze facts with the ability to develop and apply pragmatic solutions to complex compliance / E&C matters.
• Commitment to being part of a global team, including occasional required meetings at nontraditional work hours.
• Global mindset with the ability to work in a cross-functional, cross-cultural matrixed environment.
• Fluency in English (both in oral and written communication).

Travel Requirements:

• 75% remote & 25% in-office with infrequent travel requirements.

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

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