Technical Writer - PHCS

Job Summary
The Technical Writer will be responsible for creating, reviewing, revising, and finalizing high-quality documentation and labeling for the companies products. This role serves as a key point of contact between project teams and the Technical Documentation Department, ensuring timely delivery of compliant documentation in alignment with project schedules and regulatory standards. The writer will also support departmental tools, processes, and corporate standards.

Key Responsibilities
Act as primary Technical Writer on cross-functional project teams, attending meetings, tracking schedules, and reporting updates to the Documentation Supervisor.
Develop, edit, and maintain clear, accurate, and compliant documentation and labeling for product design, manufacturing, testing, release, installation, and distribution.
Facilitate the documentation review and approval process, resolving resource or timeline conflicts as needed.
Serve as liaison between project leaders and the Technical Documentation Department, conducting formal meetings and ensuring clear communication.
Use desktop publishing tools and Adobe Creative Cloud to produce professional text and graphics.
Assist in maintaining translated documents, corporate standards, and certificate library management.
Ensure compliance with quality system regulations (FDA, ISO, IVDD, 21 CFR 11) and support internal/external audits.
Maintain and improve documentation tools, processes, and performance metrics.
Collaborate effectively with interdepartmental teams, vendors, and customers.
Perform other duties as assigned by management.

Qualifications/ Education
Required: Bachelor’s degree in a scientific discipline, business administration, or related technical field.

Equivalency: Equivalent combination of education and relevant experience may be substituted.

Experience
Required: 5+ years of direct documentation experience in medical device, software, pharmaceutical, or biotechnology industries.

Required: Demonstrated knowledge of U.S. and international regulatory standards (FDA, ISO, IVDD, 21 CFR 11).

Required: Experience working on multiple projects within cross-functional teams.

Preferred: Experience with international regulatory requirements.

Technical Skills & Tools
Required: Proficiency with Adobe Creative Cloud, desktop publishing tools, and online help authoring.

Required: Experience with SAP and Google Suite.

Preferred: Skills in illustration, graphics, and screen capture.

Required: Strong knowledge of word processors, spreadsheets, project management software, and electronic document management systems.

Soft Skills & Abilities
Excellent written and verbal communication skills.
Strong organizational, negotiation, and problem-solving abilities.
Ability to work independently, manage multiple priorities, and meet deadlines.
High attention to detail and commitment to quality.
Ability to present information clearly to diverse audiences.

Pay ranges between $24-28/hr based on experience