Technical Documentation Specialist
Technical Documentation Specialist
Posted on :
11-06-2025
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1 Vacancy
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Job Description
We are seeking a skilled Technical Writer with expertise in Hematology to create clear accurate and well-structured documentation for scientific clinical or regulatory audiences. The ideal candidate will have a strong background in hematology medical or laboratory sciences and experience writing for technical or clinical stakeholders in the diagnostics pharmaceutical or healthcare industry.
Key Responsibilities:
- Develop and edit scientific and technical documentation including SOPs lab protocols manuals white papers training materials and regulatory submissions.
- Translate complex hematological concepts into reader-friendly content for clinical users lab professionals or regulatory bodies.
- Collaborate with hematologists lab scientists R&D teams and quality assurance personnel to ensure accuracy and compliance.
- Write content for hematology analyzers reagents test kits or diagnostic platforms (if applicable).
- Ensure consistency with medical writing standards regulatory guidelines (e.g. CLIA CAP FDA) and internal branding.
- Support the creation of training modules product inserts technical bulletins and clinical trial documentation if needed.
Qualifications:
- Bachelors or Masters degree in Hematology Medical Laboratory Technology or a related field.
- Minimum 2 5 years of experience in technical/medical writing preferably in a diagnostic biotech or clinical lab setting.
- Familiarity with hematology testing methods (e.g. CBC ESR flow cytometry) and instrumentation.
- Strong knowledge of regulatory documentation standards (e.g. ICH GCP GLP).
- Excellent command of written English and attention to scientific detail.
- Proficiency in MS Office referencing tools (e.g. EndNote) and document control systems.
Preferred Skills:
- Good working knowledge on Hematology process and reporting.
- Experience working with LIMS or IVD documentation.
- Knowledge of ISO 15189 CLSI guidelines or related lab quality frameworks.
- Familiarity with medical device regulations (e.g. EU MDR FDA 21 CFR Part 820).
Employment Type
Full Time
Key Skills
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