Senior Director, Regulatory Affairs Advertising & Promotion (Remote)

Job Description General Summary: The Senior Director, Global Regulatory Affairs Advertising Promotion is responsible for providing commercial regulatory strategy and oversight in the development, review and approval of product, pipeline and disease state promotional and non-promotional communications for Vertex products and development programs from stakeholders including Commercial, Medical Affairs, and Corporate Communications. This leadership role directly participates in and leads a team of regulatory reviewers on Communication Review Committees and/or Medical Review Committees (MRCs). Reporting to the VP, Global Regulatory Affairs, Advertising and Promotion, this role also provides direction for collaborative systems, processes and tactics, and on cross-functional and departmental teams, to ensure that communications and activities are compliant and meet business objectives. Key Duties and Responsibilities: Provides US/global oversight, leadership and direction to cross-functional Communications Review Committee (CRC) and Medical Review Committee (MRC) teams developing, reviewing and approving product promotion, non-promotional, and related communications, including pipeline, disease state, and medical/scientific communications. Provides direction and leadership to cross-functional teams to ensure ongoing compliance with regulatory requirements while meeting strategic corporate and business objectives. In collaboration with Medical, Legal and Commercial, provides commercial regulatory leadership and oversight to ensure that regulatory requirements are integrated in product, disease-state, and non-promotional communications. Oversees and directs Regulatory Reviewers assessing regulatory context and provide regulatory interpretations of applicable guidance and/or regulations or regulatory precedents. Enhances collaboration across a matrixed organization while developing and maintaining constructive relationships with CRC and MRC stakeholders. Directs the development of products reflective of communication considerations. Ensures that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements. Leads and directs cross-functional efforts to develop and update procedures and guidelines related to processes. Monitors and interprets advertising and promotion regulations and guidelines to support successful and compliant marketing of Vertex products; assess impact on Vertex business and stakeholders. Manages and develops individuals and/or teams. As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff. Knowledge and Skills: Expert 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. Extensive understanding of labeling regulations and U.S./global promotional review. Excellent interpersonal skills, ability to lead others, and interact with and negotiate internally/externally often at higher levels. Ability to influence others, at all levels of the organization, without direct hierarchal authority, and affect change across organizational boundaries. Demonstrated decision-making and problem-solving capabilities using complex reasoning and risk management assessments. Proven ability to influence cross-functional teams and work effectively with senior management. Excellent communication skills (oral and written), project management and presentation skills. Ability to work in fast-paced, matrixed environment with supervisory experience. Extensive pharmaceutical industry and regulatory ad/promo experience, including supervision of regulatory review team, managing launch campaigns, and interacting with Health Authorities. Education and Experience: Bachelor’s degree in relevant/scientific discipline or a related field. Typically requires 12 years of work experience and 5 years of supervisory/management experience, or the equivalent combination of education and experience. Pay Range: $216,000 - $324,000 Company Information: Vertex is a global biotechnology company that invests in scientific innovation and is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.

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