Technical Writer - 6 Month Contract

About BioAgilytix

BioAgilytix is a leader in delivering top-tier bioanalytical services that aid breakthroughs in medicine. Our team of seasoned scientists provide customized support to accelerate scientific discoveries, demonstrating unwavering commitment to customers with solution-driven approaches and strict adherence to deadlines.

Role Overview

The Technical Writer will develop study plans, methods, study reports, and various associated documents. This role demands timely production of high-quality deliverables for sponsors and internal stakeholders. Candidates with experience in a regulated GxP corporate environment are preferred, and while this is not a laboratory role, familiarity with lab assays is valued. The role requires self-motivation, independent problem-solving, and excellent attention to detail.

Key Responsibilities

• Independently author bioanalytical validation and regulatory preclinical/clinical study documents including reports, plans, and submissions.
• Extract, process, and format data from multiple laboratory systems such as LIMs, Gen5, FACs, and Microsoft Excel for integration into reports prepared with Microsoft Word.
• Understand and comply with applicable regulations and guidelines including FDA, IMA, GxP, EMA, SEND, eCTD, ensuring adherence to regulatory requirements and standard operating procedures throughout document creation.
• Use systems like ZenQMS and SharePoint for document generation and management efficiently.
• Coordinate with leadership and scientific personnel to plan and track deadlines, ensuring alignment with project timelines.
• Conduct second-tier technical reviews of documents prior to submission to project managers or principal investigators.
• Maintain direct and collaborative communication with internal team members to facilitate quality and timely delivery.
• Review and provide editorial feedback on documents prepared by other departments within BioAgilytix.
• Contribute to building the technical writing department's reputation by producing exemplary documentation, defining best practices, and driving continuous improvement aligned with company growth.

Required Qualifications and Skills

• Ability to comprehend scientific data and translate it into clear and concise written reports.
• Familiarity with laboratory scientific methods and resultant data outputs.
• Experience with regulatory frameworks including FDA, IMA, GxP, EMA, SEND, and related guidance.
• Knowledge of editorial conventions and regulatory submission standards such as SEND-ready documentation and eCTD compliance.
• Exceptional verbal and written communication skills to articulate ideas effectively.
• Strong interpersonal skills enabling collaboration across diverse teams and departments.
• High proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint) and Adobe Acrobat, adept at using advanced Word features like templates and styles.
• Flexibility to manage multiple projects concurrently and adapt to shifting priorities while meeting tight deadlines in a fast-paced environment.
• Self-directed and capable of working independently with a detail-oriented, organized approach.

Minimum Preferred Qualifications

• Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or a related scientific discipline.
• At least two years of professional experience within biotech, pharmaceutical, CRO/CMO, or related organizations with knowledge of FDA, GxP, and ICH guidelines.

Work Environment and Terms

• Full-time position, approximately 40 hours per week.
• Primarily remote work with occasional in-office visits as necessary.
• Six-month fixed-term contract.
• This contract role is not eligible for company-sponsored benefits.

Equal Employment Opportunity Statement

BioAgilytix is committed to providing equal opportunity employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, genetic testing results, military service, or other legally protected categories.

Data Processing and AI Disclosure

We employ AI tools to assist with aspects of hiring such as resume review and application analysis to identify inconsistencies or verification signals. However, final hiring decisions are made by humans. Contact us for details on data handling practices.