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Miles
Km80.5

Medical device (class III) technical writer - contract

Bulletproof Documentation, Inc.

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Location: South San Francisco, CA Posted Date: 4/22/2013 Position Type: Contract, Full time, Part time Job Code: Device Tech Writer 5 Required Education: High school or equivalent Areas of Expertise Desired: Manufacturing/Production
Quality Assurance
Technical Services

Description

• Create (from-scratch) and/or significantly rewrite documents including but not limited to design history files, design verification records, and master production records.
• Master technical information, organize content, and imbed GxP compliance
• Work independently, with minimal SME input, to draft documents and redlines.
• Meet deadlines.
• Develop training materials as required.
• Manage document review cycles, including solicitation of feedback, comment remediation, issue escalation and/or resolution, and finalization of draft document into copy-ready format.
• Schedule, lead, and facilitate document review meetings.
• Participate on project teams as needed.

Requirements

• BS/BA and at least 8 years medical device/combination product experience, 5+ years in technical writing role preferred
• Class III medical device experience a must
• Impeccable attention to detail.
• Ability to manage shifting priorities and fast pace.
• Strong written and verbal communication skills.  
• Comfortable leading teams and influencing without authority.
• Comfortable holding project team members and senior management accountable to support documentation objectives.  
• Must be fully equipped to work from home; includes personal laptop and cell phone.
• Ideal candidate has hands-on project scope experience and can speak intelligently on project related issues.
• Some travel may be required.
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