Scientific Writer

NeoGenomics Laboratories; Deutschland; Remote; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading biotechnology company is seeking a Technical Writer to create technical documentation, collaborate with various teams, and support continuous learning. This remote position requires a Bachelor's degree and at least 2 years of experience in complex diagnostic workflows. The ideal candidate will possess strong communication skills and a detail-oriented approach. Join us for competitive benefits and a culture that emphasizes career development.

Leistungen

401k match

Tuition reimbursement

16 days paid time off plus holidays

Wellness courses

Qualifikationen

• Minimum 2 years experience in high-throughput diagnostic workflows, preferably NGS-based.
• Experience in oncology preferred.
• Familiarity with CLIA/CAP lab environments and FDA regulations.

Aufgaben

• Create and maintain documentation for standard operating procedures.
• Collaborate with SMEs to gather technical information.
• Update existing documentation reflecting product changes.

Kenntnisse

Strong written and oral communication skills

Organized and detail-oriented

Ability to adapt communication to different audiences

Ausbildung

Bachelor’s in molecular biology, biochemistry, engineering or related field

Tools

Laboratory information management software (Labware preferred)

Document control (Master Control preferred)

Product lifecycle software (Codebeamer preferred)

Jobbeschreibung

Overview

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.

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

We believe in career development and empowering our employees. Not only do we provide career coaches internally, but we offer many training opportunities to expand your knowledge base! We have highly competitive benefits with a variety of HMO and PPO options. We have company 401k match along with an Employee Stock Purchase Program. We have tuition reimbursement, leadership development, and even start employees off with 16 days of paid time off plus holidays. We offer wellness courses and have highly engaged employee resource groups. Come join the Neo team and be part of our amazing World Class Culture!

NeoGenomics is looking for a 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.

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

Equal employment opportunity, including veterans and individuals with disabilities.