Director, Regl Lead, Business Integrity & Compliance (N. America)

This position has primary responsibility for all aspects of the CSL Behring regional Compliance Program in North America, specifically the US and Canada. The position will also coordinate and support global compliance initiatives under the direction of the Global Lead, Business Integrity.

1.CSL Global/ NA Regional Compliance Program: Develop, implement and maintain the requisite NA regional aspects of the CSL Global Compliance Program, including local and regional compliance policies and procedures consistent with and supportive of the CSL Global Compliance Programs and Code of Responsible Business Practice, and adjust those policies as necessary to align with the needs of the various employee and business constituencies. Actively support the Global Compliance Program as directed by the Global Lead, Business Integrity.

In collaboration with NA leadership, establish and co-lead NA regional Compliance Committee.

2.Compliance Advice and Counsel: Provide ongoing compliance guidance and support primarily to commercial operations and leadership teams- and also to Clinical, Commercial Development, and other teams as resources allow- in US and Canada by assisting/advising on, supporting development of compliant NA business practices and arrangements, including without limit: patient programs, HCP engagements (e.g. consulting, advisory board, speaker, investigator-initiated research engagements); educational grant sponsorships, congress support, and donations). Collaborate and communicate effectively with NA Legal team to support the provision of aligned compliance/ legal advice to the business as appropriate.

3.Oversight, Monitoring & Audit: Assist the Global Lead, Business Integrity in the development of, and implement, audit/monitoring programs and/or other risk detection and evaluation techniques to monitor compliance. Identify new problem areas and assist in the prevention and/or reduction of identified problems. Incorporate process improvement throughout the Compliance Program.

4.Hotline and Investigation Management: Oversee and manage the region's Compliance Hot Line, including employee training on the Hotline (availability and use) and related policies and procedures, oversight of appropriate triage and investigation of non-HR (ie compliance-related) reports, maintaining the Hotline database(s), and senior management case reporting as required.

Manage and/or direct the investigation of potential compliance issues, prepare investigation reports, and provide appropriate management updates and remediation support as needed. Recommend and enforce corrective and/or disciplinary actions for compliance and ethics issues and violations. Report incidents and breaches to the Head, Global Compliance and senior management as appropriate.

5.Compliance Training: Lead the development of business unit compliance training programs and work with business units and functions to ensure adequate visibility of compliance program initiatives.

In cooperation with the Global Lead, Business Integrity and consistent with global training plans and initiatives, develop, deliver and maintain currency of the Compliance training and education program for all CSL Behring personnel, contract workers, and key third parties as appropriate for North America.

6.Third Party Compliance Support: Develop and implement policies and processes that enable effective CSL due diligence and ongoing management of CSL third parties, including the use of appropriate compliance tools, contractual provisions, certifications/ questionnaires and training, as well as relevant audit/monitoring programs for proposed and contracted third parties.

7.Manage NA Reports: Manage and support direct reports, including assuring availability of appropriate training and development opportunities and oversight of work delegation in a manner that assures effective ongoing compliance support for key business functions and a variety of work assignments for each report.

8.External Sunshine/ Transparency/ Other Regulatory Reporting: Support and counsel NA business units implementing compliance-related regulatory initiatives and policies, including but not limited to state, provincial, and national Transparency reporting and other compliance requirements relating to HCP spend management)..

9.Compliance Systems, Tools, Communications: Work cross-functionally and with other Compliance colleagues on planning and implementing the rollout of communications from the Global Lead, Business Integrity. Work cooperatively with Legal, Internal Audit, Operations and HR on planning and implementing the rollout of compliance tools, , systems, education programs, content customizations and internal marketing communications and website updates.

Qualifications and Experience:

Education

Juris Doctor preferred, with license to practice law in PA.

Experience

Minimum of 8-10 years of experience practicing law and/or 10-12 years managing a compliance program in a health care environment, pharmaceutical compliance experience strongly preferred. Previous experience in auditing and/or law enforcement desirable.

Broad and deep working knowledge of the laws of the various jurisdictions supported.

Thorough knowledge of FCPA, UK Bribery Act, and other international/national/ local bribery and related laws.

* Thorough knowledge of laws and regulations relating to the sale and marketing of licensed products and familiarity with US health care regulations (including fraud and abuse, anti-kickback, and FDA).

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Worker Type:

Employee

Worker Sub Type:

Regular