The Senior Program Manager will coordinate delivery operations across the MarTech organization, managing integrated planning, cross-functional dependencies, and stakeholder communications. They will also support portfolio governance, release readiness, and the implementation of marketing technology initiatives.
The Regulatory Project Manager leads and coordinates global regulatory affairs advertising and promotion projects to ensure alignment with organizational objectives. They are responsible for building project management frameworks, facilitating cross-functional communication, and ensuring compliance across all regulatory submissions.
The CMC Manager will support global regulatory CMC strategies for drug-device combination products and prepare regulatory documentation for submissions. They will collaborate with cross-functional teams to ensure compliance with global regulatory requirements and design controls.
The HRIS Analyst will support the administration, maintenance, and enhancement of Workday systems while managing day-to-day operational support and reporting. They will collaborate with cross-functional teams to troubleshoot issues, perform system testing, and ensure data integrity across HR processes.
The manager is responsible for the planning and execution of international regulatory CMC submissions and lifecycle management for marketed products. They provide regulatory support to cross-functional teams and ensure product compliance regarding change controls and GMP investigations.
The Regulatory Publishing Manager is responsible for preparing submission-ready regulatory documents using advanced Microsoft Word formatting and Veeva Vault Publishing. The role ensures technical accuracy and alignment with global regulatory standards to reduce time-to-file and improve document reusability.
The role focuses on tracking and reporting privacy events and managing documentation for Quality Risk Management. Additionally, the coordinator will design and maintain a centralized SharePoint site to enable team resources and governance processes.
Support the execution of regulatory CMC strategies for marketed cell and gene therapy products. This includes planning and preparing international regulatory submissions and providing guidance to cross-functional teams on product compliance.
Provide PMO and project management support for commercial analytics and operations initiatives. This includes managing integrated project planning, governance, RAIDD tracking, and executive status reporting.
The role involves eliciting and translating business requirements into system enhancements for Veeva Vault RIM to optimize regulatory operations. The analyst will serve as a functional SME, managing data models, system integrations, and reporting dashboards to support Global Regulatory Affairs.
