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 responsibilities of the dCMC Business Owner include :

Required Skills and Experience :

Preferred Experience and Skills :

Education Minimum Requirement :

Required Skills : Accountability, Communication, Data Governance, Data Modeling, Digital Transformation, Drug Development, Key Performance Indicators (KPI), Measurement Analysis, Medicinal Chemistry, Operating Models, Operational Excellence, Portfolio, Programme, and Project Support, Program Management, Project Management, Project Planning, Regulatory Documents, Risk Management, Roadmapping, SAP Master Data Governance (MDG), Stakeholder Relationship Management, Team Leadership, Technical Management, Technical Projects, Technology Transfer, Waterfall Model

Preferred Skills :

The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.