Regulatory/Digital Medical Writer (REMOTE)

Overview

Remote
Depends on Experience
Contract - W2
Contract - 1 Year(s)

Skills

Bachelors degree
strong understanding of RMW document landscape
Clinical Study Reports (CSRs)
narratives
regulatory deliverables
Regulatory Information Management systems
data sharing platforms
digital transformation initiatives
GenAI-enabled CSR authoring
structured data workflows
document process automation
project coordination
change management
user acceptance testing (UAT)
deployment planning
tool adoption
process optimization
cross-functional collaboration
AI strategy execution
SubX capabilities (lean writing
storytelling
predictive text)
technical go-live
AI-enabled document generation
regulatory compliance.

Job Details

Please note that this is a 1-year contract position.

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

Business Impact & 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.

Top Three Skills

  1. 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.

  2. 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.

  3. 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.

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)

Applicants must provide their phone number. Reference job number A5000

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.