Matlen Silver ยท 9 hours ago
Lead Analyst, R&D Technical Writing
San Jose, CA
Contract
Onsite
Senior Level
$48/hr - $51/hrMatlen Silver is seeking a Lead Analyst for R&D Technical Writing. This individual contributor role requires professional knowledge and substantial work experience to develop and manage technical documents, ensuring compliance with regulations and standards.
Information TechnologyRecruitingStaffing Agency
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
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 demonstrating compliance to the latest regulation and standards for electronic IFUs, creation of part numbers and change management
Qualification
Required
Professional knowledge gained through substantial applicable work experience
Ability to apply principles and concepts of own subject/technical discipline in resolving issues
Attention to detail in making evaluative judgements based on the analysis of factual information
Experience in the timely development and completion of clinical reports, summary documents, package inserts, and other documents
Experience overseeing the electronic regulatory submission process
Ability to provide recommendations for the development of formats and guidelines for documentation
Experience providing guidance and direction for completion and development of clinical and pre-clinical documents
Effective planning and management of timelines for all aspects of technical documents
Experience with remediation of IFUs and labels to the latest regulation and standards for electronic IFUs
Experience with conversion of IFUs from Adobe source files to DITA xml within a content management platform
Experience with updates to content related to IFUs
Experience creating new label templates and the creation of new labels in Prisym and Adobe platforms
Experience creating documentation demonstrating compliance to the latest regulation and standards for electronic IFUs
Experience with creation of part numbers and change management
Preferred
Experience with Arbortext/Windchill
Company
Matlen Silver
Matlen Silver is a staffing agency for IT firms.
Founded in 1980
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Michele Beilman
Chief Executive Officer
Jimmy De Silver
President & Owner
Recent News
2025-11-19
2024-05-30
2023-12-10
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