The Advertising Promotion Director is responsible for providing strategic and tactical regulatory direction and support for the management of review and approval of product, pipeline and disease state communications for Vertex product(s) and/or Development program(s), including promotional and non-promotional materials and communications from varied stakeholders including Commercial, Medical, Corporate Communications and Public Affairs. This role works collaboratively and cross-functionally in the development and implementation of processes that support meeting business objectives and meet regulatory requirements.General Summary:The Advertising Promotion Director is responsible for providing strategic and tactical regulatory direction and support for the management of review and approval of product, pipeline and disease state communications for Vertex product(s) and/or Development program(s), including promotional and non-promotional materials and communications from varied stakeholders including Commercial, Medical, Corporate Communications and Public Affairs. This role works collaboratively and cross-functionally in the development and implementation of processes that support meeting business objectives and meet regulatory requirements.Key Duties and Responsibilities:Provides direction and expertise as a Regulatory expert on region/country regulations and requirements governing product promotion and related communications, including pipeline and disease state communicationsServes as Regulatory reviewer on Communications Review Committee (CRC) and Medical Review Committee (MRC), and as Global Regulatory Affairs Advertising and Promotion (GRA-AP) representative on program and other cross-functional teamsFunctions as Chair of CRC for assigned product(s) and therapeutic area(s), leading discussions between Regulatory, Legal, Medical, Commercial and other stakeholders to reach consensus CRC decisionsAs Regulatory Reviewer, assesses the regulatory context and provide regulatory interpretations of applicable guidance and/or regulations or regulatory precedents, including requirements related to submission of material to Health Authority (HA) and interact with HA, as applicableEnhances collaboration across a matrixed organization while developing and maintaining constructive relationships with CRC stakeholdersProvides direction and input for development products reflective of promotional considerationsProvides direction to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirementsProvides leadership and direction for cross-functional efforts to develop and update procedures and guidelines related to CRC processesMonitors and interprets advertising and promotion regulations and guidelines to support successful and compliant marketing of Vertex products; assesses impact on Vertex business and stakeholdersLeads training sessions as needed with stakeholdersKnowledge and Skills:High level of applied knowledge of applicable Health Authority codes, laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatmentsIn-depth understanding of clinical study design and statistical analyses in assessment of promotional claimsFamiliarity with labeling regulations and global promotional reviewExcellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures and disciplinesDemonstrates the ability to effectively adopt and leverage emerging technologies, including AI-driven tools, and maintains a continuous learning mindset to strengthen regulatory strategy, decision-making, and operational efficiency.Proactively remains up to date on advances with technology, AI, automation, competitive intelligence and changes in the regulatory environment.A solutions-driven mindset, with skills in complex reasoning and risk management assessmentsExcellent communication skills (oral and written), project management and presentation skillsPharmaceutical industry and regulatory ad/promo experience, including managing launch campaigns and interacting with Health AuthoritiesEducation and Experience:Bachelor’s degree in relevant/scientific discipline or a related fieldTypically requires 10 years of experience or the equivalent combination of education and experienceAt Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.Flex Designation:Remote-EligibleFlex Eligibility Status:In this Remote-Eligible role, you can choose to be designated as:Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or selectHybrid: work remotely up to two days per week; or selectOn-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
8 days ago