Director, Regulatory Affairs Advertising Promotion (Remote)

Job Description

General Summary:

Vertex is seeking an experienced Regulatory Affairs Advertising & Promotion Director to provide strategic and tactical regulatory direction for the review and approval of product, pipeline, and disease state communications for its pain assets in the US. This role is critical in ensuring that all promotional and nonpromotional communications meet regulatory requirements and support Vertex's business objectives. The Director will collaborate cross-functionally to develop viable communications and implement processes that drive compliance and business success.

Key Duties and Responsibilities:

• Serve as a regulatory expert on US statute, regulations, and relevant guidance governing product promotion and related communications, including pipeline and disease state communications for the pain franchise.
• Lead the Communications Review Committee (CRC), provide regulatory review support for the Medical Review Committee (MRC), and act as Global Regulatory Affairs Advertising and Promotion (GRAAP) representative on cross-functional teams.
• Chair the CRC for assigned products and therapeutic areas, leading discussions among Regulatory, Legal, Medical, Commercial, and other stakeholders to reach consensus.
• Assess regulatory context and provide interpretations of applicable guidance, regulations, and precedents, to proposed communications, as well as interpret and manage submission requirements to Health Authorities.
• Enhance collaboration across a matrixed organization and maintain constructive relationships with CRC stakeholders.
• Provide input for development products with promotional considerations, including contributions to target product profiles and proposed labeling, and ensure product labeling changes are accurately reflected in promotional materials in a timely manner.
• Lead cross-functional efforts to develop, update, and streamline procedures and guidelines related to CRC processes.
• Monitor and interpret advertising and promotion regulations, FTC and FDA compliance letters, and health authority guidances to support compliant marketing of Vertex products across a variety of communication medium.
• Lead training sessions for stakeholders as needed.

Knowledge and Skills:

• High level of applied knowledge of Health Authority statutes, regulations, guidance, and industry standards related to advertising and promotional communications for prescription drugs, devices, and investigational treatments.
• In-depth understanding of clinical study design and statistical analyses necessary to support promotional claims and other communications.
• Familiarity with labeling regulations and global promotional review.
• Excellent interpersonal, communication (oral and written), project management, and presentation skills.
• Ability to lead, influence, resolve conflict, and drive consensus among diverse stakeholders.
• Solutions-driven mindset with strong reasoning and risk management skills.
• Experience in pharmaceutical industry regulatory advertising/promotion, including managing launch campaigns and interacting with Health Authorities.

Education and Experience:

• 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

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-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.

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Company Information

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

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com