Associate Director. Technical Project Management

Job Description

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 RegulatoryAuthoring Leadership the Associate Principal Scientist Regulatory Authoring Business Owner willoptimize 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 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.

Required Skills and Experience:

• Knowledge of manufacturing testing quality and supply chain processes from late clinical development through commercialization with practical insight into how these operations generate CMC regulatory content

• Understanding of CMC operations technology transfer control strategy development and regulatory authoring requirements that inform automated filing generation

• Hands-on experience in regulatory authoring and submission documentation including preparing reviewing or supporting filing ready content and structured filing outputs.

• Proven ability to deliver results in a complex environment with shifting priorities and multiple stakeholders.

• Experience in digitization and data management initiatives in regulated environments including creation of re-usable data products data modeling and data governance.

• Working knowledge of key enterprise systems (LIMS MES SAP) and practical experience coordinating their integration into data pipelines APIs or ETL processes for downstream authoring use

• Skilled in creating and managing detailed cross-functional project plans and driving execution with accountability.

• Strong team contributor promoting an inclusive and collaborative environment

• Effective problem-solving conflict resolution and ownership-driving skills.

• Excellent verbal and written communication with the ability to tailor messages to the audience and actively listen.

• Highly organized able to prioritize tasks to ensure project success.

• Demonstrated project management skills including leading cross-functional workshops gathering and prioritizing requirements and defining and tracking KPIs.

Preferred Experience and Skills

• Experience implementing or supporting automated regulatory authoring (structured content template-driven generation or document assembly) from source systems.

• Background in analytical development or commercialization with knowledge of method development validation specification setting and justification.

• Practical knowledge of content models/structured content metadata and data template design to enable automated authoring.

• Experience with data integration patterns and tools (APIs data pipelines) and relevant systems (LIMS MES SAP).

• Experience in data governance data stewardship and data quality management in regulated environments.

Education Minimum Requirement:

• B.S. in chemistry engineering or related field with a minimum of 8 years of experience in the pharmaceutical industry

• M.S. in chemistry engineering or related field with a minimum of 6 years of experience in the pharmaceutical industry

• Ph.D. in chemistry engineering or related field with a minimum of 3 years of experience in the pharmaceutical industry

Required Skills:

Preferred Skills:

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The salary range for this role is

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 employees 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 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.

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