Associate Director, Regulatory Advertising Promotion, Pain (Remote-eligible)

Role Summary

The Advertising Promotion Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications for Vertex product(s) and/or development program(s). This role works with cross-functional teams and manages regulatory aspects of review and approval of communications and activities to ensure that the organization's needs are met in compliance with applicable regulatory requirements.

Responsibilities

• Provides specialized knowledge on region/country regulations and requirements governing product promotion and related communications, including pipeline and disease state communications
• Serves as regulatory reviewer for assigned product(s) on Communications Review Committee (CRC) and Medical Review Committee (MRC), and as Global Regulatory Affairs Advertising and Promotion representative on program and other cross-functional teams
• May serve 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
• In collaboration with Medical, Legal and Commercial, provides regulatory leadership to ensure that regulatory requirements are integrated in product and disease-state communications
• As a 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 applicable
• Provides guidance and input for development products reflective of promotional considerations
• Provides direction and work collaboratively to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements
• Collaborates in 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 and assess impact
• Plans and conducts training sessions as needed with stakeholders

Qualifications

• Thorough 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
• Strong interpersonal and communication skills communicate difficult concepts and persuade others
• Ability to innovate, analyze, and solve problems
• Pharmaceutical industry and regulatory ad/promo experience, including interacting with health authorities
• Bachelor’s degree in relevant/scientific discipline or a related field
• Typically requires 8 years of experience or the equivalent combination of education and experience

Skills

• Regulatory acumen for advertising and promotional communications
• Cross-functional collaboration and stakeholder management
• Regulatory interpretation and guidance
• Training and knowledge dissemination