$166K - 184K a year
Support AI strategy execution in Regulatory Medical Writing by enabling digitization, streamlining document processes, and deploying AI-powered solutions.
Proven experience in AI-enabled workflows, regulatory medical writing including CSRs and narratives, and strong project coordination and change management skills.
We are currently seeking an AI/Digital Transformation, Regulatory Medical Writing for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows: Job Description: • W2 only. No C2C. • Pay: 80.00-88.23/hr. • Length of Assignment: 1 year to start with potential extension. • 100% remote role. No travel required. Must be able to work EST hours. • Department: Regulatory Medical Writing (RMW). • 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. • 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 Leads to enable digitization, streamline document processes, and support the deployment of AI-powered solutions across the document lifecycle. • Support execution of the RMW functional AI strategy, including: Change management activities AI quality improvement initiatives, coordination of user acceptance testing (UAT), and 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). • Strong understanding of the RMW document landscape, including Clinical Study Reports (CSRs), narratives, and other regulatory deliverables.
This job posting was last updated on 9/19/2025