16 Nov 2016

Technical Writer

Posted By : Diana Hanson

Job Description

Position Description: 
This position is responsible for planning, research, and technical writing support 
for medical device industry product labeling within Technical 
Communication. 

 
Position Responsibilities: 
• Technical writer who provides labeling support to product development teams, including: 
o Able to translate complex product information into concise, compliant, easy-to-follow instructions for use. 
o Broad understanding of the impact of language localization and its effect on English content. 
o Intermediate understanding of project management, including development and maintenance of work breakdown structure, project schedule, and milestones. 
o Work with more senior writers to identify and mitigate assumptions, dependencies, and risks related to IFU development and implementation. 
o Successfully negotiate project schedules and implementation plans to support the labeling process. 
o Acquire subject knowledge by interviewing writers, product developers, regulatory, quality, and marketing personnel, and by referring to the product, technical specifications, and engineering 
illustrations and trade journals. 
o Manage stakeholder input and negotiate content development strategy for product development and sustaining engineering projects. 
o Basic understanding in how regulations, laws, standards, product specifications, and internal procedures impact IFU design. 
o Respond to new or changed user requirements by planning changes or improvements to IFU content. 
o Influence product implementation plan through labeling architecture and electronic labeling strategy. 
o Coordinate IFU translations through internal or external sources. 
o Coordinate the review and approval of technical documents for a project team in enterprise configuration management systems. 
o Maintain necessary records for project tracking and legal/regulatory requirements. 
• Provide technical direction and mentoring to more junior technical writers. 
• Work with translation partners to broaden the business’ understanding of content localization and the need for well-written global English content. 
• Understanding of Client’s quality system and how it impacts product labeling. 
• May participate in implementation of department projects. 
o Provide input to new procedures to implement process improvement initiatives. 
o Contribute to special initiatives, consistent with organizational objectives. 
o Apply creativity and innovation to solve problems related systems, processes, and tools. 
o Collaborate with business partners inside and outside of Technical Communication to participate in projects and to set the direction for future projects. 
• Engage in development and establishment of industry trends in technical communication, information architecture, and/or content management. 
Uses this expertise to help Client maintain its position as an industry leader in innovation. 
 

BASIC QUALIFICATIONS: 
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC 
QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME 
• Technical writing experience 
• Proven application of project management tools 
• Experience working with cross-functional project teams 
• Working knowledge of software technologies used for writing, publishing, 
and document control. 
• Understanding of project labeling development in a regulated industry. 
 

EDUCATION REQUIRED: 
• BA/BS 
 

YEARS OF EXPERIENCE: 
• 2+ years of experience in technical writing with a Masters’ degree 
• 3+ years of experience in technical writing with a BA/BS degree 

DESIRED/PREFERRED QUALIFICATIONS: 
• Understanding of the following topics: 
o ISO regulations, FDA QAR design controls, Good Manufacturing Process (GMP), etc. 
o User experience principles 
o Authoring in XML in a single-source content development environment 
o Ability to work effectively across disciplines to implement creative solutions to complex problems 
o Writing for a global audience 
• Ability to manage multiple projects 
• Ability to learn and adapt to changes in technology, processes, and requirements 
• Strong attention to detail and accuracy 
• Ability to evaluate audience and effectively communicate the appropriate level of detail 
• Ability to work independently and make sound decisions 
• Ability to take direction 
• Ability to give and receive constructive feedback 
• Excellent problem-solving skills 
• Knowledge of Client and its products

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Job Types: Contract. Job expires in 157 days.

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