Nonclinical Technical Writer – AI-Enhanced Docs

Russell Tobin

South San Francisco (CA)

On-site

USD 62,000 - 69,000

Part time

8 days ago

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Job summary

Russell Tobin is partnering with a top biotech company to identify a Nonclinical Technical Writer for an opportunity in South San Francisco, CA. The role focuses on managing non-clinical documents, metadata, and publishing within document management systems.

The candidate will perform QC, formatting, and tracking of essential study reports and regulatory summaries, while coordinating across authors, SMEs, and publishing teams to maintain timely deliverables.

Qualifications

  • Bachelor’s degree in English, science, communications, liberal arts, or health-related field.
  • Minimum 2 years of scientific editing, writing, or document management experience.
  • Knowledge of the drug development process and regulatory submissions.
  • Strong project management and organizational skills.
  • Strong written and verbal communication; ability to manage multiple projects and meet deadlines.
  • Strong attention to detail and document quality.
  • Proficiency with Microsoft Word.
  • Experience with AI-augmented tools and automation for documentation workflows preferred.

Responsibilities

  • Manage non-clinical documents across digital libraries and folder structures.
  • Capture, identify, and apply accurate metadata to files and system records.
  • Publish finalized documents and reports within document management systems.
  • Perform QC and verification to ensure documents meet readiness standards.
  • Format, edit, and track nonclinical documents, including study reports, GLP statements, CRO reports, and IND/BLA summaries.
  • Retrieve missing information through historical archives and data research.
  • Initiate document records and enter accurate system data.
  • Track document deliverables, timelines, and completion status.
  • Coordinate document hand-offs and review cycles across authors, subject matter experts, publishing teams, and stakeholders.
  • Identify document or submission issues and collaborate with teams to develop solutions.
  • Maintain internal team websites and portals and keep content up to date.
  • Communicate documentation processes and serve as an editorial resource for team members and stakeholders.

Skills

Writing & editing
Project management
Attention to detail
Communication skills
Deadline-driven

Education

Bachelor’s degree

Tools

Microsoft Word
AI tools

Job description

Russell Tobin is partnering with a top biotech company to identify a Nonclinical Technical Writer for an opportunity in South San Francisco, CA. The role focuses on managing non-clinical documents, metadata, and publishing within document management systems.

The candidate will perform QC, formatting, and tracking of essential study reports and regulatory summaries, while coordinating across authors, SMEs, and publishing teams to maintain timely deliverables.

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