The Director, Compliance Monitoring is responsible for the development and implementation of preventative and proactive compliance monitoring activities for the US organization. This role determines the activities, sources, and methods to monitor compliance with business practices, policies, laws and regulations. The job holder takes a consultative and business oriented approach; role models a culture of compliance and proactivity through leadership of the monitoring function. The Director, Monitoring reports directly to the Executive Director, US. & Enterprise Compliance and contributes to the US compliance strategy.
Job Duties & Responsibilities
Develops, builds and implements compliance monitoring programs and solutions for US Commercial and Sales activities to ensure compliance with internal and external policies, laws and regulations. Accountable for the following:
- Identifies promotional practice and related risk areas by assessing the execution of existing compliance programs through in-person reviews and data analysis.
- Attends in-person events such as speaker events or patient forums to monitor execution of compliance activities.
- Participates in sales force field rides.
- Reviews data for compliance through various means such as review of call volumes for sales representatives to healthcare providers, off-label utilization, speaker program attendance, ad boards, email reviews, prescribing numbers, etc.
- Develops mechanisms to proactively monitor compliance activities based on consultation with business partners on emerging issues and a forward-looking mindset.
- Stays abreast of changes to laws and regulations with healthcare compliance related to promotional activities.
Partners with internal teams on an integrated approach to compliance and ensures program objectives are met. Accountable for the following:
- Communicates with Business Partners and Transparency teams on field-level activities to keep abreast of emerging issues at the regional level; collaborates on ways to mitigate risk through insights derived from monitoring results.
- Identifies gaps in sales and marketing team training programs through monitoring activities and partners with Business Partners to develop content for targeted training programs.
- Identifies potential hands-off to the Compliance Investigations team for follow up.
- Performs ad hoc monitoring as needed to support non-commercial compliance activities.
Determines sources and use of systems, data and processes to support real-time monitoring and decision-making activities. Accountable for the following:
- Identifies opportunities to utilize and/or enhance technical systems and databases to support data capture, reporting and analysis.
- Develops reports and presents findings for stakeholders.
- Development and implementation of compliance monitoring programs and solutions for US business operations.
- Development of tools and resources to support the collection of data and analytics to support real-time monitoring.
- Partnership with internal teams for the ongoing management, proactive improvement and monitoring of compliance programs.
- Advanced degree and 8-10 years’ experience in a monitoring program role within a compliance, legal, internal or field audit, or risk function.
- Prior Biotechnology/Pharmaceutical industry experience including knowledge of therapeutic areas.
- Knowledge of Pharmaceutical and related healthcare compliance regulations.
- 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 data analysis tools; ability to see trends and convert information to insights.
- 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.
- Prior experience with data visualization and analytics software such as Spotfire or Tableau.
- Demonstrated ability to work collaboratively with other Compliance leaders, and with external partners.
- Flexibility and ability to adapt to changing conditions.
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