Head of Commercial Compliance, Compliance and Ethics Reports to: Location: Global Level:

SVP, Chief Compliance Officer, Compliance and Ethics Cheshire, CT Senior Director

Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and lifethreatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH, and in the United States, European Union, Japan and other countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. Further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.

 

Position Summary The person in this position will develop and direct Alexion’s ethics and compliance program covering commercial activities and will serve on the Alexion Global Compliance Leadership team, helping to develop and implement Alexion’s global ethics and compliance strategy. Specifically this role will have responsibility for: 

Developing, implementing and managing all compliance programs, processes and systems covering commercial activities. Serving as a compliance business partner for Alexion’s Commercial function and employees, providing business, ethics and compliance advice and training to enhance business operations.

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Managing Alexion’s global anti-bribery/anti-corruption compliance program, including policy development, training, auditing, monitoring and investigations. Serve/lead cross-functional teams addressing anti-bribery/anti-corruption compliance.

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Supporting/conducting compliance investigations and audits. Developing appropriate responses to investigations and audits, including remedial measures. Responding to helpline inquiries. Collaborating across departments to enhance, from an ethics and compliance perspective, business operations.

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Analyzing internal and external ethics and compliance developments and implementing responses to these developments which enhance the global ethics and compliance program.

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Serving as a member of the Compliance Senior Leadership team to continuously improve and enhance the global ethics and compliance program.

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Lead and manage other compliance professionals.

Principal Responsibilities 

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Develop and maintain knowledge and understanding of: Alexion and its global business operations and strategy; industry laws, regulations and guidelines (e.g. Federal Anti-Kickback Statute, False Claims Act), Sunshine Act, Alexion policies, procedures, and guidelines; external legal, regulatory and business developments. Develop, implement and manage a global anti-bribery/anti-corruption program addressing existing and future requirements. Work with other departments and businesses to ensure implementation of appropriate policies, training, auditing and other compliance controls covering anti-bribery/anti-corruption. Develop, implement and manage all compliance elements covering commercial activities. Work with other departments and businesses to ensure implementation of appropriate policies, training and other compliance controls covering commercial activities. Prepare regular reports of findings from the various systems; present such reports and training on other developments to business audiences, including senior leaders. Establish and implement new systems and processes to monitor and audit activities and further the Alexion compliance monitoring and auditing programs. Monitor the external environment to ensure the implementation of external best practices as well as to respond to future business, ethics and compliance developments.

Qualifications 

15+ years of experience serving in a compliance, legal, regulatory or related role, with a majority of that experience in the pharmaceutical/medical device industries. Experience working on antibribery/anti-corruption compliance preferred.

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Thorough functional knowledge of the elements of a pharmaceutical ethics and compliance program. Must possess thorough knowledge and understanding of the pharmaceutical industry and its business operations.

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Experience leading and managing a team of professionals; demonstrated experience in identifying, developing and leading talent

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Demonstrated project management skills; experience leading cross-functional teams.

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Strong business partner with a focus on collaboration and delivering results.

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Excellent written and verbal communication skills and organization skills. Fluent English, second language preferred.

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In-depth knowledge and understanding of European pharmaceutical industry laws, regulations and guidelines, including privacy and protection, anti-corruption, customer/patient interactions, etc.

Education 

BA/BS degree

Competencies 



As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.

Alexion is an Equal Opportunity /Affirmative action employer

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