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Dexian · 8 hours ago

Lead Technical Writer

San Jose, CA

Contract

Onsite

Senior Level, Lead/Staff

$50/hr - $51/hr

4+ years exp

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. They are seeking a Lead Technical Writer to assist in the development and completion of clinical reports and other documentation, while overseeing the regulatory submission process and ensuring effective management of technical documents.

ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency

H1B Sponsor Likely

Hiring Manager

Vinayak Srivastava (Ronny)

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. This job typically requires a degree or equivalent and a minimum of 4 or more years experience

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

Regulatory submissionDITA XMLTechnical writingAdobeContent managementAttention to detailIndependent work

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 attention to detail in making evaluative judgements based on the analysis of factual information

This job typically requires a degree or equivalent and a minimum of 4 or more years experience

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

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

Preferred

Preferred experience: Arbortext/Windchill

Company

Dexian

Glassdoor3.5

Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.

Founded in 1994

Mclean, Virginia, USA

1001-5000 employees

https://dexian.com

H1B Sponsorship

Dexian 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

2025 (65)