Director, Advertising Promotion (Remote-Eligible)

Vertex Inc.•Boston, MA

1d•$188,000 - $282,000•Remote

About The Position

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.

Requirements

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
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

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 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 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
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