Location: Mississauga, Canada
Job reference: R-218841
Date posted: 02/04/2025
The Associate Director, Promotional Review and Operations, will be responsible for overseeing Alexion’s Medical, Legal, Regulatory (MLR) review process, known as the Promotional Review Committee (PRC). This strategic leadership role requires deep expertise in PRC/MLR processes and the ability to collaborate effectively across diverse functions, including Commercial, Legal, Regulatory, Medical, Quality and Compliance. Reporting to the Director, Head of Promotional Review and Operations, this individual will spearhead high-priority PRC process improvement initiatives that drive operational excellence across the enterprise. In addition to managing contractors, the Associate Director will engage with senior leaders to ensure alignment and effectiveness of PRC operations.
Working closely with key stakeholders to ensure strict adherence to policies and procedures while promoting operational efficiencies and organizational effectiveness. Strong communication skills, a demonstrated ability to quickly establish positive relationships, and a focus on problem-solving are critical for success in this position. This position will play a crucial role in enhancing the efficiency and effectiveness of the PRC process, contributing significantly to the overall success and compliance of Alexion.

DESIRABLE SKILLS:

• MBA or management consulting experience.
• Prior experience in rare disease preferred and a Commercial function preferred.
  Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit of a leading biotech. You’ll join an energizing culture where people build connections to explore new ideas. As an important member of our commercial team, you’ll meet the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient’s journeys. You’re supported by exceptional leaders ready to lift you in marketing, compliance, and beyond.
  Ready to make a difference? Apply now!
  AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

• Supervise and optimize the Materials Review process and associated review systems.
• Collaborate with marketing and launch excellence teams to manage project timelines for product launches and label updates.
• Manage the PRC Excellence Forum and refine business processes for PRC/MLR to ensure streamlined and effective operations.
• Lead the execution of system enhancements and implementations, coordinating with IT and potential third-party vendors.
• Provide leadership and oversight for commercial business operations.
• Develop comprehensive communication and project plans for high-priority initiatives.
• Develop and lead annual training sessions on system functionality and process requirements to ensure user compliance.
• Conduct ad hoc reviews of PRC/MLR activities to ensure appropriate reviewers and approvers, timely document reviews, proper approvals, and resolution of exceptions.
• Design and implement efficient communication tools and resource repositories.
• Facilitate reporting functions, ensuring data accuracy and providing actionable recommendations based on data analysis.
• Partner with Legal, Compliance, and Regulatory teams to stay informed and adapt to the evolving regulatory landscape.
• Manage contractors and perform periodic audits of data and reports to ensure accuracy and compliance.