Scientific Writer

Overview

Neo Genomics 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.

Neo Genomics 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.

As a Scientific Technical Writer you will be an integral part of the Office of Innovation team  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 Neo Genomics including R&D, Clinical Development, Quality Affairs, Regulatory Affairs, Laboratory Operations, Bioinformatics, Product, and Medical teams.

• 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

• 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 Mol Dx 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