Scope
The Project's objective is to design and configure regulatory authoring templates that are needed for deployment of automation software for use in preparing chemistry, manufacturing, and controls (CMC) regulatory applications (ex. Module 3 of the ICH Common Technical Document). The project leverages 2 primary toolsets: structured content authoring (SCA) and generative AI (genAI). The regulatory authoring templates must be compatible with both technologies towards the delivery of a comprehensive automated authoring solution. The resulting templates should be created with emerging data exchange formats, such as Fast Healthcare Interoperability Resources (FHIR), in mind. There are implementation guides (IG) that can be utilized to define data requirements for FHIR CMC use case.
There Are 200 Unstructured CMC Authoring Templates That Exist In An MS-Word Based Format, Which Must Be Converted Into An Automation-ready “Connected Template” Format, In Which Data Input Fields Are Represented As Components, Which Are Units Of Product-specific And/or Reusable Data. To Create These Templates, Support Is Needed For The Following Activities

• Utilize a developing data model to “componentize” current templates to convert them to a structured, automation-ready state with data elements that are compatible with SCA software.

The 200 completed, automation-ready CMC templates are the final project deliverable. The Project will follow an iterative and collaborative approach with leadership and support from internal CMC SMEs.
Desired Expertise

• Knowledge of global CMC regulatory expectations, requirements, and relevant guidelines and legislation
• Awareness of relevant CMC/regulatory modernization initiatives (ex. PQ/CMC, KASA, IDMP, SPOR, Accumulus Synergy, ICH M4Q R2, ICH SPQS)
• Experience with using SCA and/or genAI tools for complex document assembly
• Background in data modeling, information architecture, prompt engineering, and/or database design is ideal but not required
• FHIR expertise is ideal but not required

Basic QualificationsDoctorate degree and 2 years of experience
OR
Master’s degree and 6 years of experience
OR
Bachelor’s degree and 8 years of experience
OR
Associate’s degree and 10 years of experience
OR
High school diploma / GED and 12 years of experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above