Technical Writer Molecular Diagnostics - 29790_P
BEPC Inc
Remote
$56,597 Salary, Full-Time
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Job Description
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.
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.
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 deadlinesQualifications:
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 lifecyclePreferred 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 processesKey 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 preferredWork Environment:
Hybrid work model: 3 days onsite 2 days remote Collaborative cross-functional environment supporting regulated diagnostic products Fast-paced technical documentation and regulatory settingAbout 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.
Benefits:
Dental insurance Health insurance Life insurance Vision insuranceEducation:
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 toCommute:
Branchburg, NJ 08876 (Required) Ability toRelocate:
Branchburg, NJ 08876: Relocate before starting work (Required)Work Location:
In person Technical Writer- Molecular Diagnostics
- 29790_P 3.9 3.9 out of 5 stars Branchburg, NJ 08876 Hybrid work $25.00
- $29.42 an hour
- Full-time, Contract BEPC Inc 45 reviews $25.00
- $29.42 an hour
Full-time, Contract 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.
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.
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 deadlinesQualifications:
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 lifecyclePreferred 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 processesKey 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 preferredWork Environment:
Hybrid work model: 3 days onsite 2 days remote Collaborative cross-functional environment supporting regulated diagnostic products Fast-paced technical documentation and regulatory settingAbout 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.
Benefits:
Dental insurance Health insurance Life insurance Vision insuranceEducation:
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 toCommute:
Branchburg, NJ 08876 (Required) Ability toRelocate:
Branchburg, NJ 08876: Relocate before starting work (Required)Work Location:
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