Associate Director. Technical Project Management

Digital Chemistry, Manufacturing, and Controls (dCMC) Business Owner

Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes. dCMC intends to deliver :

• Increased productivity and speed to clinic / market
• Accelerated timelines for site, filing, and launch readiness
• Improved access to product and process data
• Streamlined transfer of process and product knowledge with reduced error rates

Digital CMC will implement digital solutions to install the foundational capabilities needed to realize the vision of frictionless flow of data from development to commercialization and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation.

Under the guidance of dCMC Regulatory Authoring Leadership, the Associate Principal Scientist, Regulatory Authoring Business Owner, will optimize regulatory authoring processes and enhance data management by working with the business areas to define the optimal route to digitize the authoring of regulatory filing sections. The applicant will work closely with the cross-functional team to develop and implement the digital solution, prioritizing those features that provide the most value to the business area scientists across initial market applications, clinical submissions, and post approval supplements. In addition, the applicant will work with the extended team to develop data governance principles to ensure scalability and continued success of the developed solution.

The responsibilities of the dCMC Business Owner include :

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Preferred Experience and Skills :

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