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).Key Skills
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Employment Type : Full Time
Experience : years
Vacancy : 1