Job Title: Technical Documentation Specialist
Location: Branchburg NJ
Type: Contract
Compensation: $25-$28.17/hr
Work Model: Hybrid – onsite and remote

Responsibilities

• Lead the end-to-end development, writing, and rigorous editing of Instructions for Use (IFU) and technical labeling for complex molecular diagnostic assays.
• Translate complex scientific data into clear, compliant, and user-friendly documentation for laboratory professionals and clinicians.
• Creating and revising IFUs and Quick Reference Guides (QRGs) for molecular diagnostic products.
• Utilizing advanced Microsoft Word skills for complex document structures (nested numbering, cross-references, tables, multi-language layouts).
• Performing meticulous proofreading to ensure accuracy in scientific terminology, unit conversions, and symbol usage; adhering to ISO 13485, FDA 21 CFR Part 820, and IVDR.
• Managing full document lifecycle within an Electronic Document Management System (EDMS).
• Partnering with cross-functional stakeholders to gather content and ensure alignment.
• Managing translations of IFUs and labeling as needed.

• Proficient in MS Office
• Strong proofing and editing skills
• Comfortable working independently through the IFU lifecycle
• High attention to detail and strong organizational skills
• 2-4 years of industry experience in Medical Device or In Vitro Diagnostics (IVD) technical writing of IFUs
• Familiarity with regulatory requirements (IVDR, FDA)
• Experienced in collaborating with cross-functional teams to meet project deadlines
• Ability to spot minor discrepancies in large, complex datasets
• Associates Degree or equivalent level of education in a scientific discipline, technical writing, or other related technical field

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific