BioAgilytix is seeking a Technical Writer for a 6-month remote contract. The Technical Writer will prepare study plans, methods, study reports, and other documents, ensuring timely delivery to sponsors and internal teams in a corporate GxP setting. The role is not lab-based, but candidates with lab experience or familiarity with the assays BioAgilytix performs are preferred. This is a full-time, remote contract role with an expected duration of 6 months and is not eligible for company-sponsored benefits. Responsibilities include independently creating bioanalytical reports, plans, and submission documents to support internal projects, extracting and formatting data from lab systems (LIMs, Gen5, FACs, Excel) for inclusion in Word documents, and ensuring compliance with relevant regulations and SOPs (FDA, EMA, GxP, SEND, eCTD). The candidate will use ZenQMS and SharePoint to manage documents, collaborate with leadership and scientific staff to meet deadlines, and perform second-level technical reviews prior to project manager review. They will maintain collaborative relationships with internal teammates and provide editing for documents from other departments, aiming to elevate the technical writing function and contribute to continuous improvement aligned with BioAgilytix growth. Qualifications include a bachelor’s degree in biology, biochemistry, immunology, biotechnology, or related field; at least two years of biotech/pharma/CRO/CMO experience with FDA, GxP, ICH knowledge; strong written and oral communication skills; proficiency with Microsoft Office and Adobe Acrobat; a

BioAgilytix is seeking a Technical Writer for a 6-month remote contract. The Technical Writer will prepare study plans, methods, study reports, and other documents, ensuring timely delivery to sponsors and internal teams in a corporate GxP setting. The role is not lab-based, but candidates with lab experience or familiarity with the assays BioAgilytix performs are preferred. This is a full-time, remote contract role with an expected duration of 6 months and is not eligible for company-sponsored benefits. Responsibilities include independently creating bioanalytical reports, plans, and submission documents to support internal projects, extracting and formatting data from lab systems (LIMs, Gen5, FACs, Excel) for inclusion in Word documents, and ensuring compliance with relevant regulations and SOPs (FDA, EMA, GxP, SEND, eCTD). The candidate will use ZenQMS and SharePoint to manage documents, collaborate with leadership and scientific staff to meet deadlines, and perform second-level technical reviews prior to project manager review. They will maintain collaborative relationships with internal teammates and provide editing for documents from other departments, aiming to elevate the technical writing function and contribute to continuous improvement aligned with BioAgilytix growth. Qualifications include a bachelor’s degree in biology, biochemistry, immunology, biotechnology, or related field; at least two years of biotech/pharma/CRO/CMO experience with FDA, GxP, ICH knowledge; strong written and oral communication skills; proficiency with Microsoft Office and Adobe Acrobat; a