Our large pharmaceutical client is seeking a fully remote scientific Process Analyst to join their Structured Dossier Content Authoring project team. This role will support Dossier Development & Operations (DDO) sub-team within the project and support preparing the documentation for Business Processes for the other scientific teams within R&D Therapeutics Development & Supply to utilize. The overall project goal is to assess available technologies and then develop and implement flexible, scalable and validated solutions capable of automated generation of specified data-driven Module 3 (CMC) tables that are authored by the R&D Therapeutics Development & Supply organization. This person's primary role will be to define an implementation plan for Structured Dossier Content Authoring in Synthetics and define a business process to support automated generation and prioritization of Module 3 data tables. Other responsibilities include:
-Module 3 Gap Analysis: conduct gap analysis for Module 3, linkages across tables by reviewing the current project documentation in spreadsheet and Confluence, and input from functional leads.
-Support drafting the new Business Process to document intended steps to be taken by various personas involved in creation and use of SDCA tables. Document proposed changes and plans for implementation.
-Work with team members responsible for business process development to develop application training materials and business SMEs to develop application data cleanliness guidelines.
-Draft communications to inform stakeholders about the new process, changes, and expectations applying company and industry standard Change Management framework.
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-5+ years of experience in technical writing / scientific business process analysis and documentation
-Understanding of Large Molecule dossier content and overall outline of dossier.
-Experience in technical writing, writing user stories, best practices and stakeholder communications
-Basic understanding of data engineering activities and documentation in Module 3 in order to effectively support gap analysis for Module 3 data table preparation.
-Experience working in team environment to gather stakeholder input & user requirements and ability to navigate and connect multiple stakeholders and drive resolution.
-Knowledge of monoclonal antibody (MAb) environment and understanding of the flow of manufacturing process,
-Previous experience in Structured Content Authoring (eReporting)
-Change Management methodology experience
-Experience with SQL database queries
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.