AI Operations Analyst – Regulatory Medical Writing

Description

AI Operations Analyst – Regulatory Medical Writing

Full-Time Contractor (1-Year Initial Term)

Location: Can be Remote

Position Summary:

We are seeking a skilled and experienced contractor to support the delivery of the AI strategy within Regulatory Medical Writing (RMW). This role will work closely with the RMW AI Business Lead to enable digitization, streamline document processes, and support the deployment of AI-powered solutions across the document lifecycle.

Key Responsibilities

• Support execution of the RMW functional AI strategy, including: Change management activities AI quality improvement initiatives
• Coordination of user acceptance testing (UAT) Deployment of upgrades and expansion into new document types
• Contribute to the implementation of SubX capabilities (lean writing, storytelling, predictive text) by year-end 2026
• Assist in the technical go-live and deployment of AI-enabled Document Generation solutions (1Q–3Q 2026)

Required Qualifications

• Strong understanding of the RMW document landscape, including Clinical Study Reports (CSRs), narratives, and other regulatory deliverables Familiarity with Regulatory Information Management and Data Sharing systems
• Proven experience in digital transformation initiatives, such as: GenAI-enabled CSR authoring Structured data workflows Automation of document processes

Top Three Skills:

• Proven Experience in Digital Transformation & AI-Enabled Workflows Demonstrated success in implementing GenAI or similar technologies for document authoring and automation. Experience with structured data workflows and process optimization in a regulated environment.
• Strong Project Coordination & Change Management Capabilities Ability to support cross-functional initiatives including user acceptance testing, deployment planning, and change enablement. Skilled in organizing and driving adoption of new tools and upgrades across diverse stakeholder groups.
• Knowledge of Regulatory Medical Writing (RMW) Document Landscape Hands-on experience with Clinical Study Reports (CSRs), patient narratives, and other regulatory deliverables. Familiarity with Regulatory Information Management systems and data-sharing platforms.