Technical Writer Job at COMTEC INFORMATION SYSTEMS

COMTEC INFORMATION SYSTEMS Tarrytown, NY

As a Technical Writer/Editor, you will be responsible for:

· Manage all aspects of assay labeling projects.

· Exhibit good documentation practice understanding and implementation

· Demonstrate proficiency and provide leadership through the label process to meet company strategies and business objectives.

· Oversee the correct, complete, and compliant execution of product labeling and resolve problems and exceptions.

· Develop and maintain labeling procedures that comply with FDA, GMP, ISO and other applicable standards and regulations.

· Understand and monitor label team participation in change control.

· Assure department activities comply with established SOPs, best practices, and GMPs.

· Identify and lead process for obtaining feedback from key stakeholders for continuous improvements to label process.

· Drive continuous improvements through observation, measurement, and root cause analysis/resolution.

· Performs additional duties or assignments as directed by management.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers:

· Scientific background knowledge, understanding of data and reports.

· Medical device labeling experience

· A medical writer or medical technologist skills with ability to be a project lead.

· Abilities and skills in product/project management & organization

· Excellent verbal and written communication skills

· Must have strong collaboration skills, ability to interface with engineers, vendors and scientists.

Required skills to have for the success of this role:

· Bachelor’s degree or equivalent experience required

· Good documentation practices (folder structure, file naming, version control)

· Minimum of 3 years direct work experience leading projects or team in a medical device manufacturing company.

· Minimum of 5 years work experience with XML-based content management system (or equivalent), Adobe FrameMaker and InDesign (intermediate level).

Job Type: Contract

Salary: $30.00 - $35.00 per hour

Schedule:

  • Monday to Friday

Work Location: One location




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