Director, Labeling Strategy

Durham, United States of America | Full time | Home-based | R1563745 The Role:

IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs to be based in the US. This role is intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for new products for global markets, including the United States, European Union, the United Kingdom and Switzerland. This is a 6 month contract with the potential for extension.

RESPONSIBILITIES

Global labeling experience to provide labeling strategy support across labeling for CCDS, US, EU, Rest of World (ROW), and other major markets. Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed. Lead the Target Product Label (TPL) development for early-phase assets. Develop labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements. Support the project teams with Rest of World ROW labeling assessments against the CCDS and preparation of Health Authority (HA) responses. Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS. Effectively communicate the regulatory labeling strategy, risks, mitigation strategies and overall plans to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant. Provide input to the end-to-end labeling process. Ability to lead and manage labeling team meetings, driving strategic discussions and managing content. Provide coverage, as needed, on other products during peak periods or during absences of other team members.

SPECIFIC SKILLS

Experience facilitating meetings and driving consensus and results. Excellent leadership, co