Vertex Inc.

Compensation

Full Description

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 #LI-EE1 #LI-Remote Pay Range: $182,000 - $272,900 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible 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. #LI-Remote 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 Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.