Technical Writer (6-month contract)

As a Technical Writer your day-to-day activities will include:

• 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.

These are skills needed to be successful:

• 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)
• Excellent communication skills, both oral and written, with ability to present views in a clear and concise manner
• Strong interpersonal skills and the ability to collaborate effectively with a diversity of individuals across departments and functional groups
• 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.

Minimum Preferred Qualifications: Education/Experience:

• 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

Working Environment:

• Full-Time (40 hours/week)
• Primarily remote/work-from-home but may require in-office visits
• 6-month contract based position.
• Not benefit eligible