Scientific Writer

NeoGenomics Laboratories; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

A diagnostic laboratory company is seeking a Scientific Technical Writer for a remote position. The role involves developing technical documentation for regulatory compliance and collaborating with multiple teams. Candidates should have a Bachelor's in a relevant field and 2+ years of experience in complex diagnostic workflows. Strong communication and organizational skills are essential.

Qualifications

• 2+ years in high-throughput diagnostic workflows, preferably NGS.
• Experience writing FDA and/or NYS SOH submissions.
• Experience in oncology and CLIA/CAP labs is preferred.

Responsibilities

• Create and maintain SOPs and work instructions.
• Collaborate with R&D and QA for documentation.
• Update documentation with product changes.

Skills

Written communication

Attention to detail

Technical writing

Collaboration with SMEs

Education

Bachelor's in molecular biology or related field

Tools

Labware

Master Control

Codebeamer

Job description

Overview

NeoGenomics is looking for Technical Writer who wants to learn to continue to learn in order to allow our company to grow. This is a remote position, with a Monday – Friday day shift.

NeoGenomics is looking for a Scientific Technical Writer to join the Office of Innovation team. You will develop technical documentation and assessments to support regulatory, reimbursement, and internal resources. You will collaborate with R&D, Clinical Development, Quality Affairs, Regulatory Affairs, Laboratory Operations, Bioinformatics, Product, and Medical teams.

Position Summary

As a Scientific Technical Writer you will be an integral part of the Office of Innovation team at NeoGenomics. You will develop various types of technical documentation (including standard operating procedures, laboratory workflows, analytical validations, reports), technical assessments for managed care reimbursement (including MolDX) and regulatory bodies (e.g., NYS DOH, FDA), as well as generation or updates of internal resources (e.g., user guides, release notes).

Your role also requires collaboration with several groups at NeoGenomics including R&D, Clinical Development, Quality Affairs, Regulatory Affairs, Laboratory Operations, Bioinformatics, Product, and Medical teams.

Responsibilities

• Assist in creating and maintaining procedures and other relevant documentation to support standard operating procedures and work instructions, including validations, technical transfers, testing plans, assay optimizations, and reports
• Collaborate with subject matter experts from R&D, clinical development, bioinformatics, IT, and product teams, as well as other stakeholders to gather and understand complex technical information. This may involve interviewing SMEs, analyzing product samples, and studying product specifications.
• Collaborate with R&D, Lab Operations, and QA, as necessary for documentation drafting and review
• Update and maintain existing documentation to reflect product changes, new features, and user feedback
• The role will provide support and training to staff members as necessary

Experience, Education and Qualifications

• A Bachelor’s (BS) in molecular biology, biochemistry, engineering, or related field
• A minimum of 2 years working experience in high-throughput complex diagnostic workflows, preferably NGS-based assays
• Experience in the oncology field preferred
• Experience in working in a CLIA/CAP lab, preferably in an FDA-regulated environment for IVD under design control
• Experience writing MolDx technical assessments
• Experience writing FDA and/or NYS SOH submissions
• Experiencing authoring and preparing validation plans, reports, and Work Instructions/SOPs
• Strong written and oral communication skills, with an ability to adapt written communication to different audiences
• Organized and extremely detail-oriented
• Knowledge and understanding of laboratory information management software (Labware preferred), document control (Master Control preferred), product lifecycle software (Codebeamer preferred)
• Ability to travel up to 10% of the time