Technical Writer - Molecular Diagnostics (IFU Specialist)

Summary of the position:

BEPC is seeking a highly motivated Technical Writer – Molecular Diagnostics (IFU Specialist) to join our client’s site in Branchburg, NJ. This role will support the end-to-end development, writing, and rigorous editing of Instructions for Use (IFU) and technical labeling for complex molecular diagnostic assays.

The position focuses on translating complex scientific data into clear, compliant, and user-friendly documentation for laboratory professionals and clinicians, ensuring that every document meets strict global regulatory standards (e.g., IVDR, FDA). The Technical Writer may also be responsible for managing translations of IFUs and labeling.

Summary of Duties and Responsibilities:

• Lead the creation and revision of Instructions for Use (IFUs) and Quick Reference Guides (QRGs) for molecular diagnostic products.
• Utilize advanced Microsoft Word skills to manage complex document structures, including:
  • numbering
  • Cross-references
  • Integrated tables
  • Multi-language layouts
• Perform meticulous proofreading and technical editing to ensure accuracy in:
  • Scientific terminology
  • Unit conversions
  • Symbol usage
• Ensure all documentation adheres to:
  • ISO 13485
  • FDA 21 CFR Part 820
  • IVDR requirements
• Manage the full document lifecycle within an Electronic Document Management System (EDMS), including:
  • Drafting
  • Review
  • Approval
  • Archival
• Partner with cross-functional stakeholders to collect content and ensure alignment.
• Manage translations of IFUs and labeling as needed.

Main Qualifications:

• Associate’s Degree or equivalent level of education in: Scientific discipline, Technical writing, Related technical field.
• 2–4 years of industry experience in: Medical Device technical writing of IFUs, or In Vitro Diagnostics (IVD) technical writing of IFUs.
• Familiarity with regulatory requirements including: IVDR, FDA.
• Experience collaborating with cross-functional teams to meet project deadlines.
• Ability to identify minor discrepancies in large, complex datasets
• Experience with Electronic Document Management Systems (EDMS).
• Proficient in Microsoft Office.
• Strong proofing and editing skills.
• Comfortable working independently through the IFU lifecycle.
• High attention to detail and strong organizational skills.
• Previous IFU knowledge preferred.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Job Type:

Contract

Pay:

$25.00 - $29.42 per hour

Education:

• Associate (Required)

Location:

• Branchburg, NJ (Preferred)

Ability to Commute:

• Branchburg, NJ (Required)

Work Location:

In person