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 :

• Roadmap Definition and Ownership : Working with Digital CMC and business stakeholders, the business owner will identify the sections, plan discovery activities with the business areas, and project deliverables into a roadmap spanning clinical, first market, and post approval submissions across the pipeline. The applicant will be responsible for maintaining this roadmap in response to shifting priorities and an evolving pipeline.
• Development and Delivery Execution : The analyst will direct the efforts of a cross-functional development and delivery team to meet the business requirements. They will maintain the project backlog and continuously populate future sprints with execution ready tasks.
• Business Adoption : The applicant will oversee user testing by business representatives and drive continuous improvement through the definition and monitoring of KPIs and performance metrics. They will identify change agents within the business and educate them in the use of the application and how to enroll additional users.
• Creation of Reusable Data : The applicant will identify key data fields for contextualization within data products in support of regulatory filings for top pipeline programs. Additional use cases will be considered and prioritized appropriately to drive the adoption of data centric processes across the CMC continuum.
• Establish Standards and Governance : The applicant will set standards for structured content, data models, and governance that support scalable and compliant authoring in a sustainable way. Recommendations for data hygiene are to be developed and incorporated into the application and digitally enabled workflows.

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