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8 days old

Regulatory Affairs Technical Writer

Kelly Services
Irwindale, CA 91702
Kelly Services Outsourcing & Consulting Group is hiring for a Clinical Research Technical Writer with one of our major sponsor clients in Irwindale CA. This opportunity is a long term direct client relationship and is hourly pay to include overtime pay as time and half due to average hours being 45 a week.





**Regulatory Affairs Technical Writer**




+ Write and revise user manuals, instructions for use, and related user product instructions for medical devices and equipment

+ Interview subject matter experts

+ Research and analyze product documentation and clearly present findings

+ Edit text and layout of software screens to ensure consistency between screens and with the user product instructions

+ Remotely, and in person when necessary, attend and/or conduct meetings related to user product instructions

+ Keep track of comments made in meetings and emails about content of user product instructions and be able to retrieve that information in the future





**REQUIRED EXPERIENCE:**




+ 3+ years of relevant experience

+ Expert knowledge of advanced features of Microsoft Word 365

+ Proficient in Microsoft Excel 365

+ Familiar with PowerPoint, Visio, and graphic and photo management software.

+ Familiar with document management systems.

+ Experience working with regulated medical documentation

+ Understanding of US and EU regulations experience in clinical research or regulatory affairs preferred





**REQUIRED KNOWLEDGE AND SKILLS:**




+ Able to interview all levels of subject matter experts appropriately to obtain the appropriate information needed for user product documentation

+ Able to write documentation in a manner that users with limited to highly proficient technical product knowledge can understand.

+ Excellent English, spelling, and grammar skills and able to write clear, concise instructions in a logical sequence.

+ Able to review and edit content to ensure consistency and compliance with internal style guides, trademark usage, and other documentation standards

+ Able to write for translatability.

+ Able to develop new documentation that is similar to existing documentation and able to recommend entirely new documentation layouts

+ Preferred: Able to work on several versions of user product documentation (e.g., English only vs multilingual and worldwide content versus content for China or Japan) at the same time and keep track of the differences

+ Able to manage and meet multiple project deliverables and deadlines

+ Well organized, thorough, and detailed oriented

+ Good research, information gathering, and analytical skills

+ Able to adapt to a fast-paced, changing environment

+ Able to analyze project scope, setting interim deadlines for documentation development.

+ Able to work independently and manage time effectively

+ Able to make decisions, exhibit sound and accurate judgment, support and explain the reasoning for decisions, and include the appropriate people in the decision-making process






**Why Kelly** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-01-13 Expires: 2020-02-20

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Regulatory Affairs Technical Writer

Kelly Services
Irwindale, CA 91702

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