Technical Writer Contractor - Kenosha - MedixTM

    MedixTM
    MedixTM Kenosha

    1 week ago

    Freelance
    Description

    We're hiring a Contract Technical Writer (On-Site – Kenosha, WI)

    • 100% on site
    • 1 year contract with the chance for extension

    Seeking an experienced technical writer to support a regulated manufacturing site. This role will author and update compliant documentation in a cGMP/FDA-regulated environment and work closely with Engineering, Manufacturing, Quality, Facilities, and Supply Chain SMEs.

    What you'll do:

    • Author and revise SOPs, work instructions, protocols, test methods, and reports
    • Support documentation remediation and gap assessments
    • Manage document review/approval workflows in an EDMS
    • Ensure compliance with FDA and ICH documentation expectations
    • Participate in meetings, gather technical content, and translate it into clear, compliant documentation

    Requirements:

    • ~3+ years technical writing experience in pharma, biotech, or medical device
    • Strong experience writing FDA-compliant controlled documents
    • Ability to interview SMEs and simplify complex technical processes
    • Experience with EDMS platforms (Veeva Vault, MasterControl, or similar) preferred

    Must be local to or able to work on-site in Kenosha, WI

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