Ledgent Technology ยท 2 days ago
Lead R&D Technical Writing Analyst
San Jose, CA
Full-time
Onsite
Mid, Senior Level
$43.33/hr - $50/hr
4+ years expLedgent Technology is seeking a highly skilled Lead R&D Technical Writing Analyst to join their team. In this role, you will develop and manage technical documentation that supports regulatory compliance and product development, ensuring accuracy and clarity in adherence to industry standards.
Staffing & Recruiting
Hiring Manager
Cristina Tack
Responsibilities
Develop and finalize clinical reports, summary documents, package inserts, and other technical documentation in a timely manner
Oversee and manage electronic regulatory submission processes
Establish and maintain documentation formats, templates, and guidelines to ensure consistency and compliance
Provide expert guidance for the creation and review of clinical and pre-clinical documents
Plan and manage timelines for all technical documentation projects to meet regulatory and business requirements
Lead remediation efforts for Instructions for Use (IFUs) and labels, ensuring compliance with the latest regulations and standards for electronic IFUs
Convert IFUs from Adobe source files to DITA XML within a content management platform (preferred experience: Arbortext/Windchill)
Update and enhance content for accuracy and compliance
Create new label templates and labels using Prisym and Adobe platforms
Support change management processes, including part number creation and documentation demonstrating regulatory compliance
Qualification
Required
Bachelor's degree or equivalent with 4+ years of experience in technical writing within R&D or regulatory environments
Strong knowledge of regulatory standards for electronic IFUs and labeling
Proficiency in DITA XML, content management systems (Arbortext/Windchill), and Adobe tools
Exceptional attention to detail and ability to make sound judgments based on factual analysis
Ability to work independently with minimal supervision while managing multiple priorities effectively
Preferred
Experience with labeling platforms such as Prisym is highly desirable
Company
Ledgent Technology
Ledgent Technology, a business line of Roth Staffing Companies, utilizes proven processes and their robust professional network to place qualified technology professionals in contract, contract-to-hire, direct-hire roles and project teams throughout the US.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase