Radiant Systems Inc ยท 15 hours ago
Technical Writing Specialist
San Jose, CA
Contract
Onsite
Senior Level
$48/hr - $55/hrRadiant Systems Inc is seeking a Lead R&D Technical Writing Analyst to assist in the development and completion of clinical reports and other documentation. The role involves overseeing the electronic regulatory submission process and providing guidance for the development of technical documents, requiring professional mastery in a specialized field of expertise.
CRMInformation TechnologySoftware
Responsibilities
Assists in the timely development and completion of clinical reports, summary documents, package inserts and other documents
May oversee the electronic regulatory submission process
Oversees and provides recommendations for the development of formats and guidelines for documentation
Provides guidance and direction for completion and development of clinical and pre-clinical documents
Ensures effective planning and management of timelines for all aspects of technical documents
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision
This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent
The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive
The job requires attention to detail in making evaluative judgements based on the analysis of factual information
Primary focus on the remediation of IFUs and labels to the latest regulation and standards for electronic IFUs
IFU remediation may require conversion of the IFUs from Adobe source files to DITA xml within a content management platform (preferred experience: Arbortext/Windchill), and updates to the content
Label remediation may include creating new label templates and the creation of new labels in Prisym and Adobe platforms
Other tasks may include creating documentation demonstrate compliance to the latest regulation and standards for electronic IFUs, creation of part numbers and change management
Qualification
Required
Assists in the timely development and completion of clinical reports, summary documents, package inserts and other documents
May oversee the electronic regulatory submission process
Oversees and provides recommendations for the development of formats and guidelines for documentation
Provides guidance and direction for completion and development of clinical and pre-clinical documents
Ensures effective planning and management of timelines for all aspects of technical documents
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision
This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent
The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive
The job requires attention to detail in making evaluative judgements based on the analysis of factual information
Primary focus on the remediation of IFUs and labels to the latest regulation and standards for electronic IFUs
IFU remediation may require conversion of the IFUs from Adobe source files to DITA xml within a content management platform
Label remediation may include creating new label templates and the creation of new labels
Preferred
Experience with Arbortext/Windchill for DITA xml conversion
Experience with Prisym and Adobe platforms for label creation
Company
Radiant Systems Inc
Radiant Systems, Inc. is a certified Minority Business Enterprise, a Global Consulting company founded in 1995.
Founded in 1995
501-1000 employees
H1B Sponsorship
Radiant Systems Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (3)
Funding
Current Stage
Late StageLeadership Team
Rayn Kamesh
Head of Sales/Director, Strategic Partnership - MSP/VMS Accounts
Company data provided by crunchbase