Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional digital transformation initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes. 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.
Requirements
- Understanding of data within the CMC (Chemistry, Manufacturing, and Controls) domain, including experience in analytical testing, manufacturing processes, and laboratory development.
- Basic understanding of regulatory authoring processes and the role of data in regulatory filings, including how data supports submissions and the importance of accuracy and traceability.
- Familiarity with source systems such as LIMS, Veeva, and document formats like PDF, enabling effective data extraction, validation, and integration.
- Experience in data standardization, modeling, and semantic ontologies to define standards, maintain data models, and enhance data interoperability.
- Understanding of master data management and manufacturing ontologies to support consistent data definitions, relationships, and governance.
- Data engineering and experience with extract, transform, load tools and scripting techniques.
- Advanced knowledge of regulatory frameworks and insight to electronic submission standards (eCTD etc)
Responsibilities
- Define and implement data standardization rules and practices across multiple source systems .
- Support the extraction, transformation, and validation of process and analytical data to ensure consistency and quality before auto generation into regulatory documentation.
- Contribute to the creation and refinement of the data models that represent regulatory filing sections and their underlying data relationships.
- Assist in documenting data models, metadata, and data lineage to support transparency and traceability.
- Develop and maintain data products that enable auto-generation of regulatory filing content.
- Collaborate with product owners and technical teams to gather requirements, test new features, and trouble shoot data related issues.
- Support user onboarding and training related to data standards and product usage, including defining data governance requirements and expectations.
Other
- Proven success collaborating within cross-functional teams and communicating effectively with technical and business stakeholders to align on data requirements and project goals.
- Work closely with regulatory authoring, IT, data strategy, and source system teams to align on data requirements and understanding integration priorities.
- Participate in meetings to gather feedback, report progress, and escalate issues as needed.
- Assist in preparing documentation, reports, and presentations related to data standardization and product status.
- Hybrid work model
