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Associate Director. Technical Project Management
Associate Director. Technical Project ManagementIndianapolis Staffing • Indianapolis, IN, US
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Associate Director. Technical Project Management

Associate Director. Technical Project Management

Indianapolis Staffing • Indianapolis, IN, US
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  • [job_card.full_time]
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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.

    • 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 :

  • 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 :

  • Current Employees apply HERE
  • Current Contingent Workers apply HERE
  • US and Puerto Rico Residents Only : Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
  • As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
  • As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
  • For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit : EEOC Know Your Rights
  • We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills, and backgrounds.
  • The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
  • We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
  • Learn more about your rights, including under California, Colorado and other US State Acts
  • U.S. Hybrid Work Model
  • Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
  • This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions
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