Job Description :
Technical Writer
Fremont, CA
6-8 months contract

Interview Process: Phone screen to hire

This person is writing labels and packaging for FDA approval
Working across several groups to get required info
Any experience doing technical writing for medical or drug type of documents (will show previous work during interview)

Job Description:

We are looking for a contract worker for the next 5-6 months, preferably someone with In Vitro Diagnostic (IVD) technical writing experience who is capable of creating and finalizing highly detailed documentation in the area of IVD Packaging and Labeling specifications, Instructions for Use, Safety Data Sheets and Product Specification Brochures. This person will create specification documents, work with label designers, work with Quality and Regulatory personnel to gain approvals, prepare documents for FDA and CE Mark submissions and oversee translation of the resulting documents into multiple languages to support product launch.

The ideal candidate will:
Work collaboratively with Product Management to prioritize tasks and then be able to work somewhat independently to create specifications in formats compliant with corporate templates.
Be comfortable seeking out various department personnel to be able to create and finalize specifications, gain approvals and aide in the transition of the deliverables to production.
Participate in team meetings to report on deliverables status
Have a critical eye and take pride in their attention to detail so that the specifications and documents they create require little editing or oversight.
Have prior experience, understanding or knowledge in the area of IVD regulations and application of ISO symbols so that they can be productive right from the start.