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Job Description

The Associate Director, Regulatory Information Management is responsible for ensuring effective delivery and adoption of industry leading technologies, tools, and processes in support of the Regulatory Affairs function. This role is focused on system enhancements, process improvements, and user training to create a data-rich environment that can be used for all aspects of regulatory document and data management as well as ensuring inspection readiness. Additionally, through collaborations with the Data, Technology and Engineering (DTE) department and other functions, this role is expected to build and maintain strong relationships while pushing for the development of optimal systems, processes and data infrastructure that ensures consistency and cross functional alignment across the organization.

Key responsibilities include:

• Define the technical direction of Vertex Regulatory systems and technology, including incremental improvements to reduce complexity and increase adoption as well as long-term strategic projects, enhancing analytics and reporting, and ensuring scalability aligned with Vertex’s growth.
• Work with functional area stakeholders to assess and prioritize system enhancements and business needs related to technology and process optimization.
• Provide oversight and support to business during requirements definition, systems and process design, data migration, data cleansing and user acceptance testing activities.
• Drive the communication to and education of users on business tools and the functional impact to workflows and processes, including oversight and development of training content, formal business guidelines and reference material.
• Ensure data flow is streamlined and centralized to maximize accuracy, completeness and reduce redundancy.
• Lead the development of role-specific training curriculum for the Vertex Regulatory Information Management (RIM) system.
• Partner with departmental training coordinator to ensure GxP training captured in our learning management system is appropriate and aligned with the updated curriculum.

Education & Experience

• Bachelor's degree, with a preference for life sciences or technology area

• Typically requires 8+ years of experience in a business analyst role or the equivalent combination of education and experience.
• Experience with Veeva Vault RIM suite or similar software systems.
• Experience with eCTD publishing solutions.
• Experience collecting and documenting user requirements and translating to system enhancement requests.
• Experience with system training and documentation.
• Experience leading remote and in-person training courses.

Knowledge & Skills

• Demonstrated knowledge of global regulatory submission, document, and data management processes.
• Ability to organize, multi-task and prioritize work; problem solve while meeting aggressive timelines.
• A collaborative and flexible team player who is willing to support a variety of activities as needed
• Strong initiative, work ethic and ability to deliver results with little oversight; Demonstrates good judgment
• Highly organized and able to manage and coordinate schedules.
• Ability to communicate effectively to a wide range of audiences with varying skill sets and/or levels of seniority.
• Excellent presentation, administrative and communication skills

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

1. Hybrid and work remotely up to two days per week; or select

2. On-Site and work 5 days per week with ad hoc flexibility.

#LI-EE1 #LI-Hybrid

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