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Technical Writer - IVD (Contract)

Apply Share Job ID 1047 Category Research & Development Job Location Redwood City, California Posted Date 07/21/2018

Overview:

POSITION SUMMARY:

Genomic Health is seeking a highly motivated and collaborative individual for a contract (8-12 months) position as a Technical Writer. This candidate will report to the Senior Director, Product Sciences and will be involved in in-vitro diagnostics (IVD) product development. The candidate's primary responsibility will be to support IVD development, verification and validation under design control by authoring a wide range of documents. This candidate will work closely with cross-functional teams to write, edit, review and finalize technical documents associated with product development, product verification and validation.



RESPONSIBILITIES / DUTIES:
· Writing, editing and reviewing design control documents, including SOPs, study protocols and reports, software and other documents supporting verification and validation.
· Organizing and incorporating information for documents, such as references, graphics, tables, and data listings.
· Represent the technical writing viewpoint within cross-functional meetings.



QUALIFICATIONS:

· Bachelors/Masters in a scientific/technical discipline or equivalent
· IVD experience
· At least 3-5 years of technical writing experience in the IVD field; experience in writing, reviewing and editing design control related documents
· Strong knowledge of molecular biology and molecular biology methods (e.g. PCR, quantitative PCR, sequencing, ELISA), prior laboratory experience a plus
· Experience writing design control documentation for Software as a Medical Device.
· Knowledge and/or experience writing technical documentation for software development life cycle (SDLC).
· Ability to write with scientific accuracy and to compile, write, and edit documents for submission to regulatory agencies.
· Understanding of regulations and guidelines governing IVD products, with a broad knowledge of related topics such as Quality Assurance, Reagent Manufacturing, and Product Development
· Knowledge of ISO 13485 and medical device documentation and associated regulatory requirements would be an advantage.
· Able to facilitate clear communication with stakeholders
· Agile and flexible team player with the ability to effectively cope with the challenges of meeting aggressive deadlines
· Proven ability to multitask, collaborate in cross-functional teams, and work independently
· Critical-thinker able to address complex situations, issues, and adopt a systemic view of continuous process improvement to reach goals
· Excellent working knowledge of English grammar, punctuation and overall writing skills, with the ability to edit content for user-facing documentation
· Proficient with Microsoft Word, Excel and PowerPoint
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!