Scientific Writer

CellCarta•Lake Forest, CA

1d•$30 - $35•Hybrid

About The Position

Scientific Writer Are you ready to launch your career in the exciting world of clinical trials and biotech? We're seeking a driven and detail-oriented Scientific Writer to join our dynamic team. This entry-level role offers the opportunity to gain hands-on experience and grow your expertise in a fast-paced, innovative environment. As a key member of our team, you will have the opportunity to work with cutting-edge technology, collaborate with cross-functional teams, and gain valuable experience. Get ready to take your first step in a rewarding career in the biotech industry and join us today! Summary The Scientific Writer is responsible for writing and quality control (QC) of scientific or technical documentation, including validation reports, clinical trial and non-clinical study reports, data presentations, training guidelines, standard operating procedures (SOPs), and other scientific documentation generated at the CellCarta Lake Forest site. This role also involves writing study plans and analytical plans for client studies and serving as backup to the client services team in preparing study budgets.

Requirements

1-2 years of relevant scientific/technical writing experience.
Ability to produce high-quality scientific content with precision and clarity.
Attention to detail in grammar, formatting, referencing, and scientific accuracy, with a commitment to maintaining consistency across documents and projects.
Ability to work with cross-disciplinary teams.
Strong communication and interpersonal skills.
Some experience in managing multiple concurrent projects with competing deadlines, ensuring timely delivery of high-quality deliverables in a fast-paced, client-driven setting.
Ability to organize and effectively present validation, clinical, and non-clinical data using tables, figures, and visual tools that meet scientific and regulatory standards.
Comfortable using document management systems and writing tools (Microsoft Office suite) and statistical analysis methods.
Knowledge of regulatory requirements and relevant QA guidelines.

Nice To Haves

Experience with histopathology, anatomic pathology, and immunohistochemistry (IHC) is strongly preferred.
Knowledge of genomics, FISH, ISH, immunofluorescence is a plus but not required.

Responsibilities

Prepare, edit, or review documentation that includes but is not limited to assay validation reports, optimization/characterization reports, clinical and non-clinical study reports, study plans, analytical plans, SOPs, training guidelines, continuing education materials, and presentations.
Prepare clear, accurate, and insightful manuscript-style final study, optimization/characterization, and validation reports, which include an introduction, materials and methods, results, discussion, and references. Results may be presented with tables, graphs, statistical analysis, and photomicrographs. Technical document templates are usually available; however, custom reports may be requested.
Review study plans/analytical plans and deliverables to ensure that all raw data is available for reports. Report any missing deliverables or documentation to the project manager or assay development scientist.
Prepare PowerPoint presentations that may incorporate a synopsis of the study, methods, images, results, and conclusions. Presentations may be prepared for project updates during meetings between assay development scientists and clients for assay development studies. Presentations may also be prepared for project updates during meetings between project managers and clients for clinical and non-clinical studies.
Prepare study plans and analytical plans outlining work to be completed for clients in accordance with the study budget. Prepare updates to these documents throughout the study as requested by project managers and assay development scientists in new versions of the document.
Perform QC of all documentation types responsible for preparing as process dictates. Provide clear and insightful feedback to ensure the quality of all documentation created by the scientific writing team.
Manage and maintain trackers for all deliverable deadlines. Notify supervisor, project manager or assay development scientist, or deliverable requestor in a timely manner of any expected or actual delays.