Scientific Technical Writer- Medical Devices- Autoimmunity

Overview

Job Summary

The Scientific Technical Writer will be responsible for creating, editing, and maintaining high-quality documentation for Biotech IVD instrumentation and reagent projects. This includes authoring and revising CAPAs (Corrective and Preventive Actions), V&V (Verification & Validation) reports and protocols, and other quality and regulatory documents. The position supports the R&D and Quality teams by ensuring all documentation meets internal standards and regulatory requirements.

Responsibilities

Key Accountabilities

• Develop, edit, and maintain technical documentation, including CAPAs, V&V reports, protocols, and quality documents for in-vitro diagnostic instruments.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to gather information and ensure accuracy and completeness of documentation.
• Ensure all documents comply with company procedures, regulatory standards, and design control requirements.
• Participate in document reviews, audits, and updates as required.
• Support the creation and maintenance of Design History Files (DHF) and other records as needed.
• Translate complex scientific concepts into clear, concise, and accurate documentation for internal and external audiences.
• Communicate effectively with cross-functional teams to clarify requirements and resolve documentation issues.

Networking/Key relationships

• R&D teams: Assay Development and Biomarker discovery
• Manufacturing and Operations Teams
• Quality & Regulatory Teams
• Global Systems Support
• Software and Hardware Teams (within Werfen or external)

Qualifications

Minimum Knowledge & Experience for the position:

 

Bachelor’s in Life Sciences, Engineering, or related field (Master’s a plus). At least 3 years’ technical writing experience in biotech, medical device, or IVD sectors.

 

Skills & Capabilities:

• Experience with design control processes and document control systems.
• Familiarity with V&V documentation, CAPA processes,and quality management systems.
• Strong attention to detail, organizational, and communication skills
• Proficiency with Microsoft Office (Word, Excel, Acrobat).
• Experience with in-vitro diagnostics or medical device documentation.
• Knowledge of regulatory standards (FDA, ISO 13485, etc.).
• Ability to work independently
• Ability to manage priorities across multiple projects simultaneously.

Travel requirements:None required.

 

 

The hourly range for this role is currently $36.00 range to $46.00 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

 

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com