What are the responsibilities and job description for the Scientific Technical Writer- Medical Devices- Autoimmunity position at Werfen North America?
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
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
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 sta tus, 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
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.
- 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)
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.
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 sta tus, 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
Salary : $36 - $46