System One
Overview
Job Title : Technical Writer
Location : Remote (candidates local to Tucson, AZ preferred)
Pay Range : $30.00 - $35.00/hr
Type : Contract, Potential for extension or conversion to permanent
Key Responsibilities
Serve as the primary Technical Writer on cross-functional project teams; attend project meetings, track schedules, and provide status updates to the Documentation Supervisor
Develop, edit, and maintain clear, accurate, and compliant documentation and labeling supporting product design, manufacturing, testing, release, installation, and distribution
Facilitate documentation review and approval processes, addressing resource constraints or timeline conflicts as needed
Act as liaison between project leadership and the Technical Documentation Department, including leading formal documentation-related meetings
Produce professional documentation using desktop publishing tools and Adobe Creative Cloud
Support maintenance of translated documentation, corporate documentation standards, and certificate library management
Ensure documentation complies with applicable quality system regulations (FDA, ISO, IVDD, 21 CFR Part 11)
Support internal and external audits related to documentation and labeling
Maintain and continuously improve documentation tools, workflows, and performance metrics
Collaborate effectively with internal teams, external vendors, and customers
Perform additional duties as assigned by management
Required Qualifications
Bachelor’s degree in a scientific discipline, business administration, or related technical field
Equivalent combination of education and relevant experience may be considered
Minimum
5+ years
of direct technical documentation experience within medical device, software, pharmaceutical, or biotechnology industries
Demonstrated knowledge of U.S. and international regulatory standards (FDA, ISO, IVDD, 21 CFR Part 11)
Experience supporting multiple concurrent projects in a cross-functional environment
Preferred Qualifications
Experience supporting international regulatory requirements
Background in highly regulated life sciences or medical device environments
Technical Skills
Proficiency with
Adobe Creative Cloud
and desktop publishing tools
Experience with
SAP
and
Google Workspace
Strong working knowledge of word processing, spreadsheets, project management tools, and electronic document management systems
Preferred experience with illustration, graphics creation, and screen capture tools
Core Competencies
Excellent written and verbal communication skills
Strong organizational, negotiation, and problem-solving abilities
Ability to work independently and manage multiple priorities in a deadline-driven environment
High attention to detail and commitment to documentation quality and compliance
Ability to present technical information clearly to diverse audiences
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Location : Remote (candidates local to Tucson, AZ preferred)
Pay Range : $30.00 - $35.00/hr
Type : Contract, Potential for extension or conversion to permanent
Key Responsibilities
Serve as the primary Technical Writer on cross-functional project teams; attend project meetings, track schedules, and provide status updates to the Documentation Supervisor
Develop, edit, and maintain clear, accurate, and compliant documentation and labeling supporting product design, manufacturing, testing, release, installation, and distribution
Facilitate documentation review and approval processes, addressing resource constraints or timeline conflicts as needed
Act as liaison between project leadership and the Technical Documentation Department, including leading formal documentation-related meetings
Produce professional documentation using desktop publishing tools and Adobe Creative Cloud
Support maintenance of translated documentation, corporate documentation standards, and certificate library management
Ensure documentation complies with applicable quality system regulations (FDA, ISO, IVDD, 21 CFR Part 11)
Support internal and external audits related to documentation and labeling
Maintain and continuously improve documentation tools, workflows, and performance metrics
Collaborate effectively with internal teams, external vendors, and customers
Perform additional duties as assigned by management
Required Qualifications
Bachelor’s degree in a scientific discipline, business administration, or related technical field
Equivalent combination of education and relevant experience may be considered
Minimum
5+ years
of direct technical documentation experience within medical device, software, pharmaceutical, or biotechnology industries
Demonstrated knowledge of U.S. and international regulatory standards (FDA, ISO, IVDD, 21 CFR Part 11)
Experience supporting multiple concurrent projects in a cross-functional environment
Preferred Qualifications
Experience supporting international regulatory requirements
Background in highly regulated life sciences or medical device environments
Technical Skills
Proficiency with
Adobe Creative Cloud
and desktop publishing tools
Experience with
SAP
and
Google Workspace
Strong working knowledge of word processing, spreadsheets, project management tools, and electronic document management systems
Preferred experience with illustration, graphics creation, and screen capture tools
Core Competencies
Excellent written and verbal communication skills
Strong organizational, negotiation, and problem-solving abilities
Ability to work independently and manage multiple priorities in a deadline-driven environment
High attention to detail and commitment to documentation quality and compliance
Ability to present technical information clearly to diverse audiences
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