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Req ID: 24132 Job Category: Compliance Location: Boston, MA Posting Date: October 26, 2020 This position can be remote/virtual, based anywhere in the United States and may require up to 20% travel to existing Alexion sites.
Reporting into the SVP, International Compliance & Global Compliance Operations, the Head of Global Compliance Operations ("GCO") is responsible for the design, implementation, and oversight of the Company's global compliance systems and tools including global risk assessments, auditing and monitoring programs. Partnering with colleagues in Compliance and other key management functions such as Internal Audit, Finance, Legal, the Head of GCO will manage and direct strategies to implement control and systems across the organization to manage key risks and assess both compliance risk and the efficacy of related mitigating activities (e.g., policies, procedures, and controls) across key business activities, including third-party relationships (e.g., healthcare organizations, healthcare professionals (HCPs), and other third parties), external funding, travel and entertainment, commercial and medical engagements, patient interactions and engagements. Similarly, the Head of GCO will be responsible to partner with these colleagues to design and coordinate the implementation of activities tailored to assessment and monitoring outcomes. The Head of GCO will be responsible for strengthening Alexion's global compliance program and related strategies across three key dimensions: (1) risk assessment, auditing, and monitoring activities; (2) enhancement and alignment of processes and systems to ensure appropriate integration and consistency; and (3) utilization of both qualitative and quantitative data analytics.
Job Duties & Responsibilities
Leveraging existing efforts and resources, the Head of GCO is responsible for designing, implementing, and overseeing Alexion's global compliance systems, global analytics and compliance risk assessment monitoring programs across the Company's global activities. In coordination across Compliance and with other key functions, the Head of GCO will be responsible for efforts to establish a regular global assessment of the Company's compliance risk profile, and tailor risk-based monitoring efforts across activities including, third-party engagements and transactions, external funding activities, travel and entertainment, commercial and medical engagements, patient interactions and engagements. Building on assessment and monitoring findings, the Head of GCO is responsible to oversee the evaluation and monitoring of existing risk-mitigation efforts, including the Compliance program and related systems and controls, and to coordinate cross-functional efforts to design and implement enhancement strategies to ensure the constant evolution of Alexion's Compliance program globally.
Among other things, the Head of GCO is responsible for the following:
Designing, implementing and overseeing Alexion's global compliance systems;
Leveraging existing efforts to design, implement, and oversee a global risk assessment program analyzing both the Company's compliance risk profile, and the efficacy of mitigation efforts in coordination with the Global Compliance Leadership Team;
Developing and launching a global compliance monitoring framework and program across the enterprise (U.S. and ex U.S.);
Coordinating across functions to integrate compliance risk assessment and monitoring, as appropriate, (e.g., alignment with Internal Audit on internal audit work plans to integrate current risk assessment findings and compliance program monitoring);
Analyzing aggregate qualitative data (e.g., audit reports, investigative findings, proactive review reports) and qualitative data from various systems, including Alexion's Anti-Bribery/Anti-Corruption (ABAC) approval system (ARIES), Concur, SAP, VEEVA, among other systems and tools, to effectively assess and monitor compliance risk and program efficacy across the organization;
Overseeing Alexion's Global Monitoring Tool, including both the ongoing evolution of the tool, and how the tool is utilized across the organization (e.g., access, dashboards, governance for escalation of risks or identified transactions);
Designing and implementing dynamic and static reporting across relevant stakeholders including as examples, dynamic heatmaps and dashboards utilized by business and compliance leaders, static reports on key assessment and monitoring activities (e.g., annual risk assessment and monitoring reports), and coordinating across the Compliance function to provide reporting on the Company's risk profile and monitoring efforts to groups such as senior management, compliance committees, and leadership teams;
Establishing mechanisms to support the collection of data and analytics to conduct proactive, real-time monitoring across key activities, including third-party engagements, external funding, T&E, and patient engagement;
Collaborating with relevant stakeholders across the Compliance team and other risk-management functions such as Legal, Finance, and Internal Audit, to ensure an integrated approach to compliance risk assessment, auditing, and monitoring, and related processes and systems;
Providing broad support across compliance teams by developing auditing and monitoring plans, implementing process and system enhancements, and supporting remediation, as necessary;
Drafting and implementing relevant internal compliance policies, procedures, tools and resources, and guidance as needed to execute risk assessment and monitoring strategies; and
Serving as a collaborative, business-oriented member of Alexion's Global Compliance team.
10-12 years of relevant experience in a monitoring and/or compliance operations role within a Compliance, Legal, Audit, or Risk function (including experience with risk assessment, monitoring, data analytics, and systems oversight);
Excellent communication skills, both written and verbal;
Experience in drafting and implementing policies, procedures, and guidance documents;
Ability to collaborate and work well with others, and operate in a matrixed, multi-cultural environment;
Strong leadership capabilities and project management skills;
Excellent analytical and organizational skills;
Ability to think strategically and innovatively, and find solutions;
Be a team player and collaborate effectively across functions and within the Compliance team;
Demonstrated ability to work collaboratively with senior management, compliance leaders, and with external parties;
Flexibility and ability to adapt to changing conditions;
Strong commitment to ethics and responsibility; and
Ability to travel, as required, to meet business needs.
Direct experience building, implementing, and overseeing compliance systems, risk assessment and monitoring programs, both U.S. and ex-U.S.;
Prior biotechnology/pharmaceutical industry experience;
Prior experience with data visualization and analytics software such as Qlik Sense or Tableau is helpful; and
Working knowledge of data modeling and database management systems.
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years,Alexionhas developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD).Alexionalso has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor.Alexionfocuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered inBoston, Massachusetts,Alexionhas offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com .
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.
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