广告推广总监
Director, Advertising Promotion
**职位描述**
**总体概述:**
广告推广总监负责为Vertex产品和/或开发项目的审查和批准管理提供战略和战术监管方向和支持,包括产品、管线和疾病状态的传播内容,以及来自商业、医学、企业传播和公共事务等不同利益相关方的宣传和非宣传材料和传播内容。该职位需要与各方协作并跨职能合作,制定和实施支持实现业务目标并符合监管要求的流程。
**主要职责和任务:**
- 作为监管专家,为地区/国家的监管法规和要求提供指导和专业知识,包括产品推广及相关传播内容,包括管线和疾病状态传播
- 担任传播审查委员会(CRC)和医学审查委员会(MRC)的监管审查员,并作为全球监管事务广告与推广(GRA-AP)代表参与项目和其他跨职能团队
- 担任指定产品和治疗领域的CRC主席,领导监管、法律、医学、商业和其他利益相关方之间的讨论,达成CRC决策的一致意见
- 作为监管审查员,评估监管背景并提供适用指南和/或法规或监管先例的监管解释,包括向卫生当局(HA)提交材料的要求以及与HA的互动
- 在矩阵式组织中加强协作,同时发展和维护与CRC利益相关方的建设性关系
- 提供指导和输入,以开发反映宣传考虑因素的产品
- 确保产品说明的变化按照公司程序和监管要求纳入宣传材料
- 领导跨职能工作,制定和更新与CRC流程相关的程序和指南
- 监控和解读广告和推广的法规和指南,以支持Vertex产品的成功和合规营销;评估对Vertex业务和利益相关方的影响
- 根据需要为利益相关方开展培训会议
**知识和技能:**
- 对适用法规有高水平的实际应用知识
查看英文原文
**Job Description**
**General Summary:**
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.
**Key Duties and 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
**Knowledge and Skills:**
- 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
**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
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
**Pay Range:**
$188,000 - $282,000
**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