At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing!
The Technical Writer is responsible for the preparation of study plans, methods, study reports, and other documents. He or she ensures the timely delivery of high-quality documents for sponsors and internal team members. We are looking for candidates who have experience in a corporate GxP setting. This role is not lab-based, but our best candidates have lab experience or experience with the types of assays we do here. You are self-motivated, an independent thinker, and highly detail oriented.
This position is a full-time, remote contract role with an expected duration of 6 months . As a contract position, it is not eligible for company-sponsored benefits .
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