Senior Manager, Advertising and Promotional Compliance, US

This is what you will do: The Senior Manager, Advertising and Promotional Compliance, US serves as the Regulatory Affairs (RA) representative on product promotion and medical review teams. The Senior Manager will also play a critical role in the continual assessment of the Veeva review platform and provide feedback as needed to better optimize the system for the regulatory reviewer. Attends promotional review meetings and provides regulatory guidance to the cross-functional team responsible for ensuring adherence to global compliance standards and FDA regulations pertaining to prescription drug advertising and promotion, as applicable • This role will also review US medical materials and attend medical review meetings and provide regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance standards and FDA regulations pertaining to scientific exchange, as applicable • Serves as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253 • As needed, provides training support within Alexion on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences • In collaboration with their manager, provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products • Ensures stakeholder awareness of proposed and newly approved labeling changes • Inform, review and provide clear communication to all key stakeholders in both PRC and MRC on planned label updates and how they may impact promotional and medical materials; provide key stakeholders with specific guidance on appropriate implementation of the label update, including ISI updates, for assigned therapeutic area in a timely manner • In collaboration with their manager and MLR Coordinator, develop processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company products • In collaboration with the ad/promo team, monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, Enforcement Actions published by OPDP, and by attendance of major industry/FDA conferences and meetings; the role will also work with management and cross-functional partners to analyze changes to the regulatory landscape and determine any internal impact and communicate and provide guidance to all impacted key stakeholders • Collaborate with ad/promo team and Reg Ops on creation and implementation of novel submission processes • Participates/assists in US labeling negotiations and FDA meetings as necessary You will need to have: • Bachelor’s degree • 3-5 years of relevant experience or relevant PharmD post-doctoral Fellowship experience • Solid knowledge of US advertising and promotional regulations • Experience communicating and negotiating directly with OPDP • Experience with global standards for advertising and promotion compliance preferred • Proven track record practicing sound judgment as it relates to risk assessment • Knowledgeable on industry compliance requirements and non-compliance examples and trends • Demonstrated ability to influence others and foster team collaboration • Strong interpersonal, communication and leadership skills • Proven ability to prioritize and meet critical business timelines • Experience with launching new products and/or new indication • Ability to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate • Solid understanding of business goals and common marketing concepts/tools, including the internet and social media • The duties of this role are generally conducted in an office environment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. We believe that the more inclusive we are, the better our work will be.