Senior Specialist Regulatory Compliance

Overview

On Site
$83 - $88
Contract - W2
Contract - 12 month(s)
No Travel Required

Skills

Digital Transformation
AI-Enabled Workflows
GenAI Document Authoring
Document Process Automation
Structured Data Workflows

Job Details

Job Description:

Pay Range: $83.23hr - $88.23hr

Requirements:
  • 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.
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 Candidateagement and Data Sharing systems.
  • Proven experience in digital transformation initiatives, such as: GenAI-enabled CSR authoring.
  • Structured data workflows, Automation of document processes
Business Impact and Risk:
  • This role is critical to ensuring timely development and deployment of AI technologies for Document Generation, Review, and Quality Control.
  • Without this resource, key milestones may be delayed, impacting operational efficiency and innovation delivery.
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 Candidateagement Capabilities.
  • Ability to support cross-functional initiatives including user acceptance testing, deployment planning, and change enablement.
  • Skilled in organizing and driving the 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 Candidateagement systems and data-sharing platforms.
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