Technical Writer – 6-month contract

BioAgilytix

Technical Writer preparing high-quality study plans and reports for BioAgilytix's bioanalytical services. Requires experience in a corporate GxP setting with a scientific background.

Posted 7/26/2026contractRemote • North Carolina • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in bioanalytical report creation and regulatory compliance, with a strong understanding of FDA, GxP, and ICH guidelines. Proficient in data manipulation and technical writing, ensuring high-quality documentation that meets industry standards.

Highest-signal resume keywords

Bioanalytical Report CreationRegulatory Compliance (FDA, GxP, ICH)Data Manipulation and FormattingTechnical Writing and DocumentationMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Bioanalytical Report CreationData ManipulationTechnical WritingLaboratory-Based Scientific MethodsRegulatory Guidelines KnowledgeMicrosoft ExcelMicrosoft WordAdobe AcrobatSEND DocumentationECTD Compliance

Soft Skills

Organizational SkillsProblem SolvingAdaptabilityAttention to DetailCollaboration

Tools & Technologies

LIMsGen5FACsZenQMSSharePoint

Industry Keywords

BiotechPharmaceuticalCROCMORegulatory Submissions

About the role

Key responsibilities & impact

Takes ownership of independently creating bioanalytical reports, plans, and submission documents mostly in support of internal BioAgilytix projects including validation and regulatory preclinical/clinical study sample analysis.
Proficiently extracts, manipulates, and formats data from multiple lab systems (e.g., LIMs, Gen5, FACs, Microsoft Excel) for integration into reports (Microsoft Word).
Demonstrates understanding to relevant regulations and guidelines (e.g., FDA, IMA, GxP, EMA, SEND, eCTD); ensures regulatory requirements and appropriate SOPs are followed in all documentation.
Utilizes ZenQMS, SharePoint and other systems proficiently for creation and management of internal documents.
Collaborates with appropriate leadership and scientific personnel to develop and monitor deadlines associated with deliverables ensuring alignment with study timelines.
Responsible for second-level technical review of documents prior to review by the project manager (e.g., Bioanalytical Project Manager (BPM), Principal Investigator).
Responsible for maintaining collaborative, direct contact relationships with internal team members.
Collaborates with and provides review and editing for documents authored by other departments within BioAgilytix.
Apply professional expertise to establish and enhance the technical writing department's reputation by developing high-quality documentation, setting best practices, and actively contributing to continuous improvement initiatives that align with the company’s growth objectives.

Requirements

What you’ll need

Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field
Not less than two (2) years of experience working in a biotech, pharmaceutical, CRO/CMO, or similar organization; including knowledge of FDA, GxP and ICH guidelines
Ability to understand scientific data and deliver clear and concise reports
Must have a familiarity with laboratory-based scientific methods and corresponding data outputs
Demonstrated experience with working regulations and guidelines (e.g., FDA, IMA, GxP, EMA, SEND)
Knowledge of standard editorial/style conventions (e.g., SEND ready documentation for FDA submission and eCTD document compliance)
High level of proficiency in Microsoft Office (Outlook, Word, Excel, and PowerPoint) and Adobe Acrobat; ability to use Word templates and style features
Versatility, flexibility, and willingness to concurrently manage projects and work within constantly changing priorities; ability to work under pressure and tight deadlines in a fast-paced team environment
Demonstrated ability to work independently in a fast-paced team environment.
Excellent organizational skills, problem solving, adaptability, and attention to detail.

Benefits

Comp & perks

Not benefit eligible