Associate Director, Promotional Review and Operations
4 days ago
When we put unexpected teams in the same room, we fuel ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.
The incumbent will be responsible for coordinating 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 role will engage with senior leaders to ensure alignment and effectiveness of PRC operations.
Working closely with key stakeholders, the Associate Director will ensure strict adherence to policies and procedures while promoting operational efficiencies and organizational effectiveness. Exceptional communication skills, a proven ability to quickly build positive relationships, and a solutions-oriented mindset are essential for success in this role. 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.
You will be responsible for:
Oversee 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 run 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. Lead contractors and perform periodic audits of data and reports to ensure accuracy and compliance.You will need to have:
Bachelor’s degree in a relevant field. 8+ years of biotech/pharma experience, specifically in Commercial Operations and Materials Review (PRC/MLR). Proficiency with PRC/MLR systems like Veeva PromoMats. Strong project management skills and experience working with geographically dispersed teams. Excellent organization skills, lead multiple projects simultaneously. Strong written and verbal communication skills, including ability to present to senior management. Consistent track record of effective functional and cross-functional leadership. Thorough, self-starter, capable of working independently and as part of a team. Experience with formalized organizational change processes. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:
MBA or management consulting experience. Prior experience in rare disease preferred and a Commercial function preferred.At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
Alexion 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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Ready to lead and inspire? Apply now and take the first step towards an exciting career at Alexion, AstraZeneca Rare Disease.
Date Posted
10-Jun-2024Closing Date
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
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