Lead R&D Technical Writing Analyst

This range is provided by Ledgent Technology. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$43.33/hr - $50.00/hr

Direct message the job poster from Ledgent Technology

We are seeking a highly skilled Lead R&D Technical Writing Analyst to join our team. In this role, you will play a critical part in developing and managing technical documentation that supports regulatory compliance and product development. You will work independently, applying your expertise to ensure accuracy, clarity, and adherence to industry standards

• 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.

• 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.
• Experience with labeling platforms such as Prisym is highly desirable.
• 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.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.

For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

• Associate

• Full-time

• Administrative and Writing/Editing

• Writing and Editing