Technical Writer

 
The selected candidate will provide technical writing / editing for technical files related to the Quality Management System.   Ensuring accuracy and continuity across related documentation covering Standard Operating Procedures, Work Instructions, Drawings, Quality Documents, Product Validation and other technical documents.  Works closely with Production, Engineering, Business Development, R&D and Sales Operations to create professional documentation.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES
 
¿    Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles.
¿    Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables.
¿    Critically analyze, synthesize, and present complex information in well-constructed documents.
¿    Review and edit documents, including those authored by others both internally and externally.
¿    Ability to support multiple projects and to prioritize work independently.
¿    Ability to comply with company and/or industry style guides and templates.
¿    Ability to negotiate and integrate different viewpoints, relay and receive information and collaborate in a team environment.
¿    Ability to coordinate and manage communications to enable timely reviews from authors and reviewers and to function as a collaborative team player.
¿    Promote standardization of submission process within the company.
¿    Advanced MS Skills in Word, Excel, and Adobe Pro.
¿    Interpret information into clear and concise scientific writing and apply applicable FDA regulations for the writing and publishing of regulatory submissions.
¿    Write, review, edit multi-volume documents requiring advanced word processing and formatting, indexing, generation of table of contents, and manual pagination according to FDA regulations.
 
REQUIRED EDUCATION AND EXPERIENCE
 
¿    High School diploma or equivalent 
¿    Must possess a minimum of 3 years of experience in technical editing and writing and have strong writing and editing skills, including ability to manipulate usage and grammar.
¿    Fluent written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy.
¿    Must have demonstrated knowledge of file configuration management, strong writing and editing skills, including ability to manipulate usage and grammar.
¿    Must have demonstrated ability to query authors for clarity and compliance purposes and must be skilled in Microsoft Word, MS excel, and PowerPoint (for the purpose of editing electronically).
 
 

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Reference number US_EN_99_020641_384651