Technical Writer - Regulatory (Contract Position)

Truveta

Contract Position

Summary

This job is a contract position for a Technical Writer - Regulatory at Truveta. The role involves creating and maintaining documentation to support compliance with FDA Real World Data (RWD) regulations, working closely with subject matter experts and engineering teams, and ensuring the accuracy and quality of technical content.

What you'll do

  • Work cross-functionally with engineering stakeholders and SMEs, to ensure the accurate and prompt completion of well-supported regulatory documentation
  • Provide editorial support, ensuring quality of all technical content, with a focus on clarity, grammar, accuracy, and consistency, while adhering to proper format, regulatory requirements, and company guidelines/styles/drafting processes
  • Systematically track and notate documentation history and manage version control, ensuring the most up-to-date and accurate versions are available to the team

Requirements

  • Bachelor’s degree in a technical field supplemented by training. Advanced certification, degree preferred
  • At least 2 years' experience as a Medical/Regulatory/Technical writer or equivalent writing experience
  • Experience with FDA regulations, Quality Management Systems (QMS) is highly desirable
  • Experience in the preparation of regulatory documentation for RWD is highly desirable
  • Strong experience and knowledge of cloud technology and engineering industry processes and regulations
  • Track record of consolidating, analyzing/interpreting, summarizing, and communicating data from multiple data sources effectively in writing for a regulatory audience
  • Analytical ability to swiftly grasp and effectively communicate scientific and engineering concepts
  • Ability to work effectively, accurately, and take accountability on critical compliance timelines
  • Demonstrated ability to drive and see tasks through to completion
  • Excellent interpersonal and active listening skills; establishes and maintains productive working relationships with team members
  • Candidates must work regular business hours during pacific time zone
  • Contract will go through 3/1/2024

Apply

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Location

Seattle, WA

Contract Length

Contract will go through 3/1/2024.

Compensation

$70 - $80 (per hour)

Keywords

fda regulations quality management systems (qms) cloud technology engineering industry processes and regulations rwd (real world data) sops (standard operating procedures) technical specifications manuals

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