The Director, Transparency & Compliance Operations is responsible for defining and implementing the transparency and aggregate spend compliance strategies and programs and oversees operational aspects of US compliance programs. The Director acts as a subject matter expert translating Centers for Medicare and Medicaid Services (CMS), Fair Market Value (FMV) and Healthcare Professionals and Organizations (HCP/O) reporting requirements into the development of policies, procedures and training programs to ensure Alexion meets federal and local compliance requirements. The job holder takes a consultative and business oriented approach; role models a culture of compliance and proactivity through leadership of the transparency and aggregate spend function. The Director, Transparency and Compliance Operations reports directly to the Executive Director, US. & Enterprise Compliance and contributes to the US compliance strategy.
Job Duties & Responsibilities:
Develops the strategies, standards, and processes by which Alexion will capture, manage and report Aggregate Spend and transparency data to regulatory agencies. Accountable for the following:
- Designs business processes, programs and strategies to ensure organization-wide compliance with reporting requirements; develops processes to ensure US Commercial and Sales teams comply with established policies.
- In partnership with Finance, identifies, tests and refines process for capturing and reporting payments in the General Ledger.
- Makes recommendations on changes to processes, systems, tools and resources used to manage transparency and aggregate spend programs.
- Develops policies and procedures covering both internal and external resources (e.g. vendor management) to ensure accuracy and timeliness in data capture and reporting.
- Corresponds with CMS or other regulatory agencies on enquiries related to reported information.
Partners with internal teams on an integrated approach to compliance and to ensure program objectives are met. Accountable for the following:
- Identifies issues at the field level with sales and marketing teams and provides guidance and collaboration with Compliance Business Partners on solutions to mitigate the risks through training, policies and communication.
- Identifies trends or outliers that require hand-off to the Monitoring team to provide ongoing review and monitoring; takes a proactive forward looking approach to integrating with other parts of the compliance functions.
- Partners across both the compliance and finance functions to ensure proactive anticipation of trends and to ensure both efficiency and effectiveness in current and anticipated approaches.
Manages US compliance operations, including oversight of the U.S. HCP Engagement strategies and process; manages coordination of internal data management systems used to monitor, analyze and report compliance related outcomes (e.g. IT data warehouses, financial systems, salesforce systems). Accountable for the following:
- Manages the execution and completion of HCP Engagement related processes across all relevant Alexion entities and key functional areas (e.g., Legal, Finance, Commercial, IT, etc.), stakeholders, third party vendors, and IT system vendors in the US. Ensures that documentation substantiates business needs and planned Engagement strategies.
- Provides advice and partnership with internal stakeholders on the implementation of U.S. HCP Engagement activities, ensuring activities adhere to laws and regulations while in the planning stages.
- Provides operational leadership on key compliance activates. Ensures that activities are aligned with Corporate Compliance objectives.
- Executes on strategy, policy, and procedures related to HCP Engagement/Transparency.
- Maintains visibility to, and understanding of, Alexion’s internal data and finance systems, including: Master Data Management, SAP, Concur, etc.
- Development of programs to ensure compliance with Transparency and Aggregate Spend regulations.
- Identification and implementation of end to end processes to capture, audit, report, and ongoing management of data related to programs.
- Management of US based HCP Engagement strategies and processes.
- Advanced degree and 8-10 years’ experience managing transparency / aggregate spend programs.
- Prior Biotechnology/Pharmaceutical industry experience.
- Excellent communication skills both written and verbal; developing and presenting communications, recommendations and findings to leadership teams.
- Excellent problem solving and analysis skills including use of analysis tools and understanding of related finance processes and methods.
- Deep knowledge of data management systems used across the organization to manage, monitor, track and report compliance outcomes including an understanding of the required data sources, data warehousing and the related operational aspects of compliance
- Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and leader.
- Strong sense of ethics and responsibility.
- Ability to travel as required to meet business need.
Boston, MA, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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