[Hiring] Advertising Promotion Director @Vertex Inc.

Role Description

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.

• 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 communications.
• Serves 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 teams.
• Functions 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 decisions.
• As Regulatory Reviewer, assesses the regulatory context and provides regulatory interpretations of applicable guidance and/or regulations or regulatory precedents, including requirements related to submission of material to Health Authority (HA) and interacts with HA, as applicable.
• Enhances collaboration across a matrixed organization while developing and maintaining constructive relationships with CRC stakeholders.
• Provides direction and input for development products reflective of promotional considerations.
• Provides direction to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements.
• Provides leadership and direction for cross-functional efforts to develop and update procedures and guidelines related to CRC processes.
• Monitors and interprets advertising and promotion regulations and guidelines to support successful and compliant marketing of Vertex products; assesses impact on Vertex business and stakeholders.
• Leads training sessions as needed with stakeholders.

Qualifications

• 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 treatments.
• In-depth understanding of clinical study design and statistical analyses in assessment of promotional claims.
• Familiarity with labeling regulations and global promotional review.
• Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines.
• Demonstrates 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 assessments.
• Excellent communication skills (oral and written), project management and presentation skills.
• Pharmaceutical industry and regulatory ad/promo experience, including managing launch campaigns and interacting with Health Authorities.

Requirements

• Bachelor’s degree in relevant/scientific discipline or a related field.
• Typically requires 10 years of experience or the equivalent combination of education and experience.

Benefits

• Annual bonus and annual equity awards.
• Eligible for overtime pay, in accordance with federal and state requirements.
• Inclusive market-leading benefits including medical, dental and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and the Winter.
• Educational assistance programs including student loan repayment.
• Generous commuting subsidy and matching charitable donations.
• 401(k) and more.

Company Description

Vertex is a global biotechnology company that invests in scientific innovation.