Remote Bioanalytical Technical Writer (6-Month Contract)

BioAgilytix Labs, LLC; United States; Remote; USD 60,000 - 90,000; Full time

Job summary

BioAgilytix Labs, LLC is seeking a Technical Writer for a full-time, remote contract role with an expected duration of 6 months. The position is not eligible for company-sponsored benefits.

You will prepare study plans, methods, reports, and submission documents for sponsors and internal teams in a GxP environment. Ideal candidates have lab experience or familiarity with the assays BioAgilytix performs, and you should be self-motivated, detail-oriented, and able to work independently in a

Qualifications

• Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field.
• Two+ years of experience in biotech, pharmaceutical, CRO/CMO, or equivalent with FDA, GxP and ICH knowledge.
• Experience in a corporate GxP setting is preferred.

Responsibilities

• Create bioanalytical reports, plans, and submission documents for internal BioAgilytix projects.
• Extract, manipulate, and format data from lab systems for reports in Word.
• Ensure compliance with FDA, ICH, GxP, EMA, SEND, and eCTD guidelines.
• Use ZenQMS, SharePoint, and other systems to manage internal documents.
• Collaborate with leadership and scientists to meet deadlines and study timelines.
• Perform second-level technical reviews before project manager review.
• Maintain collaborative relationships with internal teams and other departments.
• Contribute to establishing best practices and continuous improvement in technical writing.

Skills

Scientific data interpretation

Lab data familiarity

Regulatory knowledge

SEND documentation

Communication skills

Cross-functional collaboration

MS Office proficiency

Attention to detail

Education

Bachelor’s degree in molecular biology/biochemistry/immunology/biotechnology or related field

Job description

BioAgilytix Labs, LLC is seeking a Technical Writer for a full-time, remote contract role with an expected duration of 6 months. The position is not eligible for company-sponsored benefits.

You will prepare study plans, methods, reports, and submission documents for sponsors and internal teams in a GxP environment. Ideal candidates have lab experience or familiarity with the assays BioAgilytix performs, and you should be self-motivated, detail-oriented, and able to work independently in a