Technical Writer Molecular Diagnostics - 29790_P

Job Title:

Technical Writer•Molecular Diagnostics (IFU Specialist)

Location:

Branchburg, NJ (Hybrid•3 Days Onsite / 2 Days Remote)

Employment Type:

W2 Contract•6 Months with possible extensions

Pay Rate:

$25.00•$29.42/hour (determined by experience, paid weekly)

Schedule:

Monday•Friday | 8:00 AM•4:30

PM Benefits:

Medical, Dental, Vision, and Life Insurance Note:

This is a W2 only role — C2C and C2H candidates will not be considered.

Role Overview:

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, editing, and management of Instructions for Use (IFUs) and technical labeling documentation for complex molecular diagnostic assays. The position focuses on translating scientific and technical information into clear, compliant, and user-friendly documentation for laboratory professionals and clinicians while ensuring adherence to global regulatory standards including IVDR and FDA requirements. The Technical Writer may also support translation management activities for IFUs and labeling materials.

Key Responsibilities:

Lead the creation, revision, and maintenance of: Instructions for Use (IFUs) Quick Reference Guides (QRGs) Technical labeling documentation Utilize advanced Microsoft Word skills to manage: Numbering structures Cross-references Integrated tables Multi-language document formatting Perform detailed proofreading and technical editing to ensure: Scientific accuracy Correct terminology Proper unit conversions Consistent symbol usage Formatting accuracy Ensure documentation compliance with:

ISO 13485 FDA 21 CFR

Part 820 IVDR requirements Manage the full document lifecycle within Electronic Document Management Systems (EDMS), including: Drafting Review coordination Approval workflows Archival activities Collaborate with cross-functional stakeholders to gather technical content and ensure document alignment Support translation management for IFUs and labeling documentation as needed Identify discrepancies within large and complex datasets and documentation Maintain organized documentation practices while managing multiple priorities and deadlines

Qualifications:

Associate's Degree or equivalent education in: Scientific discipline Technical Writing Related technical field 2-4 years of industry experience in: Medical Device technical writing In Vitro Diagnostics (IVD) IFU documentation Familiarity with regulatory requirements including:

IVDR FDA

regulations Experience collaborating with cross-functional teams to meet project deadlines Strong proofreading, editing, and organizational skills Ability to identify discrepancies within complex technical documentation and datasets Experience using Electronic Document Management Systems (EDMS) Proficiency with Microsoft Office Suite, especially Microsoft Word Ability to work independently and manage multiple priorities throughout the IFU lifecycle

Preferred Qualifications:

Previous IFU writing experience in molecular diagnostics or IVD products Experience managing multilingual documentation and translations Familiarity with GMP or regulated medical device environments Experience supporting document control and quality systems processes

Key Skills Required:

Microsoft Office Suite Proofreading and technical editing IFU development and formatting Regulatory documentation support Strong written communication skills Attention to detail and organization Previous IFU knowledge preferred

Work Environment:

Hybrid work model: 3 days onsite 2 days remote Collaborative cross-functional environment supporting regulated diagnostic products Fast-paced technical documentation and regulatory setting

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. Apply Now! Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights technical writing, IFU development, proofreading, and regulatory documentation experience. Please include specific examples demonstrating your expertise with medical device or molecular diagnostics documentation and compliance standards.

USOPS Pay:

$25.00•$29.42 per hour

Benefits:

Dental insurance Health insurance Life insurance Vision insurance

Education:

Associate (Required)

Experience:

Medical Device technical writing: 2 years (Required) In Vitro Diagnostics (IVD) IFU documentation: 2 years (Required) Electronic Document Management Systems (EDMS): 2 years (Required)

Location:

Branchburg, NJ 08876 (Preferred) Shift availability: Day Shift (Required) Ability to

Commute:

Branchburg, NJ 08876 (Required) Ability to

Relocate:

Branchburg, NJ 08876: Relocate before starting work (Required)

Work Location:

In person