The Technical Writer will work with all functions to create and edit a wide variety of technical, compliance and intellectual property related documents. This will involve interviewing functional area experts as well as refining existing draft documents. This person will also be a contact and technical expert for the Electronic Document Management System (EDMS).
Specific Responsibilities
Write a variety of documents, including (but not limited to); user manuals, requirements, specifications, design documents, verification / validation documents, procedures and regulatory filings. Work with functional areas to ensure that protectable intellectual property from all sources is captured and appropriately documented. Manage (with Quality staff) the routing and approval of documents. Ensure consistency of format, content and conventions in documents. Develop and / or improve required templates. Act as a point of contact for the EDMS. This includes training, troubleshooting and account management. All other duties as assigned.
Qualifications
Specific Skills and Competencies
Proactive, seeks input from others within work group and other internal experts to evaluate various options and build consensus for the best solutions Expert level technical writing skills System focused, effective cross-functional communicator Team oriented, positive can-do attitude Objective evaluator of job tasks and processes on how well they help meet work group objective(s); attempts to identify non-value-adding components and barriers. Highly detail-oriented with the ability to also grasp and focus on the larger project direction and vision
Education / Experience Level
Bachelors Degree from an accredited four year university. Five years or more technical writing experience in the medical device, in-vitro diagnostic or pharmaceutical industry. Experience with EDMS. Familiarity with ISO-13485 and / or 21 CFR 820. Experience with Regulatory Submissions a plus.
Additional Information
We have a fun and challenging environment where fun and hard work are valued. All of this combined with the ability to produce world changing technology makes Advanced Liquid Logic an amazing place to work!
All your information will be kept confidential according to EEO guidelines.
Advanced Liquid Logic, Inc - 10 months ago
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