Technical Writer (IFU & Labeling)

Pride Health is seeking a Technical Writer (IFU & Labeling) for one of the world's largest biotech companies.

Job Title:

Technical Writer (IFU & Labeling)

Location:

Branchburg, NJ - Hybrid (3 days on site, 2 days remote)

Job Type:

Contract Length:

6-

Months Hours:

Mon-Fri, 8am-4:30pm

Pay Rate:

$23.00 - $26.60 per hour

Overview:

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.

Responsibilities:

• 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. Who You Are
• Associates Degree or equivalent level of education in a scientific discipline, technical writing, or other related technical field
• 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

Preferences:

• Previous IFU knowledge Benefits that Pride Health offers: Pride Health offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

Apply Today! If you are interested in the position, please email your resume to rob.vanriet@pride-health.com for immediate consideration. #E2

EProf Pay:

$23.00 - $26.60 per hour

Benefits:

Health insurance Vision insurance

Work Location:

Hybrid remote in Branchburg, NJ 08876