Technical Writer – 6-month contract

🔥 4 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🔏 Technical Writer

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BioAgilytix

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

BioAgilytix is a leading provider of bioanalytical services trusted by biopharmaceutical companies to deliver quality data and expertise at every stage of drug development. With over 30 years of experience, BioAgilytix specializes in demanding areas of bioanalysis, such as method transfer, assay creation, sample analysis, and commercial diagnostic testing. The company collaborates closely with clients to ensure precise, on-time results that withstand regulatory scrutiny, aiding in the creation of therapies that transform patient care. BioAgilytix is highly recognized for its scientific expertise, regulatory excellence, and consultative approach, serving clients across the globe.

📋 Description

• 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

• 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

• Not benefit eligible