Job Description

The Technical Writer is responsible for developing instructional and informational materials that ensure the safe, appropriate, and effective use of scientific and technological products and services. This role involves creating and managing technical documentation, manuals, and work instructions while ensuring compliance with company documentation and quality assurance standards.

Key Responsibilities:

• Develops and manages user documentation projects, including work instructions, style guides, and process documentation.
• Collaborates with technical teams to gain in-depth product knowledge.
• Reviews, revises, and approves existing documentation for consistency and quality improvement.
• Investigates issues (INVs/CAPAs) and recommends documentation changes to address root causes.
• Supports project teams by coordinating documentation timelines and deliverables.
• Manages translation projects and vendor communications as needed.
• Oversees documentation workflows through regulatory submission and production phases.
• Ensures compliance with FDA regulations and ISO requirements.
• Implements continuous improvement initiatives for documentation processes.

Qualifications & Skills:

• Education: Bachelor’s degree preferred (technical degree advantageous).
• Experience: 5-8 years of experience (or 2-5 years with a technical degree).
• Technical Skills: Proficiency in Adobe FrameMaker, MadCap Flare, InDesign, Author-IT, and MS Office.
• Additional Knowledge: Experience with PLM systems, Agile, HTML, CSS, and source controls like GitHub/TFS is beneficial.
• Soft Skills: Strong communication, project management, problem-solving, and analytical abilities.

Thank You

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