Head of Compliance Operations, Compliance and Ethics

Transcription

1 Head of Compliance Operations, 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: Position Summary The person in this position will develop and direct Alexion s global compliance operations, including global transparency, monitoring, reporting and auditing systems, among others. The person will help develop and implement Alexion s global ethics and compliance strategy. The person will manage a team of professionals. Specifically this role will have responsibility for: Developing, implementing and managing a global transparency program addressing existing and future transparency requirements. Managing all compliance systems, including the Company s helpline, auditing/monitoring systems, and other compliance processes and systems. Analyzing internal and external ethics and compliance developments and developing and implementing responses to these developments which enhance the global ethics and compliance program.

2 Serving as a business partner for other Alexion departments and businesses, providing business, ethics and compliance advice and training to enhance business operations Serving as a member of the Compliance Senior Leadership team to continuously improve and enhance the global ethics and compliance program Lead and manage a team of compliance professionals Principal Responsibilities 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 transparency program addressing existing and future transparency requirements. Manage and enhance Alexion s global aggregate spend system, including the team surpporting this system. Collaborate with other professionals managing other transparency requirements (e.g., clinical trial transparency). Manage all compliance systems, including Alexion s helpline, incident database, reporting and auditing systems. Manage the team(s) operating those systems. Serve on and lead crossfunctional teams in the operation, development and enhancement of those systems. 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 department monitoring and auditing program. 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 or related role, with a significant amount of that experience spent managing, implementing or supporting compliance systems. At least 5 years of that experience must be in the pharmaceutical/medical device industries. Thorough functional knowledge of the elements of a pharmaceutical ethics and compliance program as well as the systems and processes that support such a program. Must possess thorough knowledge and understanding of the pharmaceutical industry and its business operations. Experience leading and managing a team of professionals; demonstrated experience in identifying, developing and leading talent

3 Demonstrated project management skills; experience leading cross-functional teams. Strong business partner with a focus on collaboration and delivering results. Excellent written and verbal communication skills and organization skills. In-depth knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g. FDA, PhRMA Code, Federal Anti-Kickback, False Claims, etc.) Education BA/BS degree Competencies <<list the competencies required for the role. For a complete list of competencies or for help in completing this section, please reach out to your HR Business Partner>> 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 or download our App for iphones and Blackberries. Alexion is an Equal Opportunity /Affirmative action employer The information below this point is required but will not be displayed in an online job posting. Leveling

4 Select the criteria that best matches the level of the new job. The drop-down menus below are based on the general criteria for determining the internal Global Job Level of a job. The criteria are general only and are organized by job type (Management (usually supervises people), Specialist, Scientific, or Support) and ascend in order of level. Experience & Know-How Choose the skill level that describes this job best. Management Jobs: A trusted leader and aknowledged expert with expertise in their field. Problem Solving & Complexity Choose from the menu below the level of complexity & problem solving that is normal for this job. Management Jobs: Job works with Senior Managment on complex and sometimes abstract problems covering functional areas of the business. Decision Making & Accountability: Choose from the menu below the level complexity & problem solving that is normal for this job. Management Jobs: More strategic, with limited operational focus. Have full accountability for their functional area. Management Responsibility: Choose from the menu below the kinds and levels of personnel managed by this job Job Manages up to Associate Directors Dimensions / Quantitative Data Section May Not Apply to All Jobs. This information will not be displayed in an online job posting. Budgetary Responsibility if any: Geographic Scope if any: Global Direct reports if any: 2 Indirect Reports (if any): Revenue / Sales (Country Managers Only): Others: Physical Requirements for the Job US Only (Select all that apply) This information will not be displayed in an online job posting. Physical Elements Choose an item. Choose an item. Choose an item. Lifting pounds Carrying pounds Other:

5 over distances Mental Elements Choose an item. Other: Equipment Use Lab Equipment (Specify): Vehicle (specify): Other: Environmental Conditions Choose an item. Choose an item. Choose an item. For Compensation Use Only: This information will not be displayed in an online job posting. FLSA Status: Job Code/Job Title: Job Classification: GxP: