Technical Writer (6-month contract)

About the role

BioAgilytix delivers tailored bioanalytical services to support new medicine breakthroughs. As a Technical Writer, you will prepare study plans, methods, study reports, and other documents, ensuring timely delivery of high-quality documentation for sponsors and internal teams. This is a full-time, remote contract role with an expected duration of 6 months. While not lab-based, candidates with lab experience or familiarity with bioanalytical assays are preferred.

Responsibilities

• Independently create bioanalytical reports, plans, and submission documents for internal projects, including validation and regulatory preclinical/clinical study sample analysis.
• Extract, manipulate, and format data from lab systems (e.g., LIMs, Gen5, FACs, Microsoft Excel) for integration into reports (Microsoft Word).
• Ensure compliance with relevant regulations and guidelines (e.g., FDA, IMA, GxP, EMA, SEND, eCTD) and adherence to SOPs in all documentation.
• Use ZenQMS, SharePoint, and other systems for document creation and management.
• Collaborate with leadership and scientific personnel to develop and monitor deadlines for deliverables, aligning with study timelines.
• Perform second-level technical reviews of documents before submission to the project manager (e.g., Bioanalytical Project Manager, Principal Investigator).
• Maintain collaborative relationships with internal team members and provide review/editing support for documents authored by other departments.
• Apply professional expertise to enhance the technical writing department’s reputation by developing high-quality documentation, setting best practices, and contributing to continuous improvement initiatives.

Requirements

• Ability to understand scientific data and deliver clear, concise reports.
• Familiarity with laboratory-based scientific methods and data outputs.
• Experience with regulations and guidelines (e.g., FDA, IMA, GxP, EMA, SEND).
• Knowledge of editorial/style conventions (e.g., SEND-ready documentation for FDA submission and eCTD compliance).
• Excellent oral and written communication skills, with the ability to present views clearly.
• Strong interpersonal skills and ability to collaborate across departments.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint) and Adobe Acrobat, including Word templates and style features.
• Versatility, flexibility, and willingness to manage multiple projects under tight deadlines in a fast-paced environment.
• Ability to work independently and adapt to changing priorities.
• Excellent organizational skills, problem-solving, adaptability, and attention to detail.

Qualifications

• Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or a related field.
• Minimum of two (2) years of experience in a biotech, pharmaceutical, CRO/CMO, or similar organization, with knowledge of FDA, GxP, and ICH guidelines.

Schedule

• Full-time (40 hours/week).
• Primarily remote/work-from-home, with potential in-office visits.
• 6-month contract position.

This contract role is not eligible for company-sponsored benefits.