ALOIS Solutions · 1 day ago
R&D Technical Writing
San Jose, CA
Contract
Onsite
Mid Level
4+ years expALOIS Solutions is seeking an Analyst for R&D Technical Writing. The role involves developing clinical reports and documentation while ensuring compliance with regulations and standards.
ConsultingHuman ResourcesStaffing Agency
Hiring Manager
Jaikumar J.
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
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
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
Company
ALOIS Solutions
ALOIS Solutions is a rapidly expanding Talent and Technology Solutions company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Farhad Wadia
Co-Founder
Kinjal Desai
Co-Founder
Recent News
2025-05-17
2025-04-14
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