Job Description
Job Description
Russell Tobin is partnering with a top biotech company to identify a Nonclinical Technical Writer professional for an opportunity in South San Francisco, CA.
Responsibilities:
- Manage and process 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
Requirements:
- Bachelor’s degree in English, science, communications, liberal arts, health-related field, or a related discipline
- Minimum 2 years of scientific editing, writing, or document management experience
- Knowledge of the drug development process and regulatory submissions required
- Strong project management and organizational skills
- Strong written and verbal communication skills
- Ability to manage multiple projects and meet aggressive deadlines
- Strong attention to detail and document quality
- Ability to anticipate, troubleshoot, and resolve issues impacting timelines
- Proficiency with Microsoft Word
- Experience with AI-augmented tools and automation for documentation workflows is preferred
Additional Details:
- Location model: South San Francisco, CA 94080
- Position Type: 12-month contract with potential to extend
- Pay range approved: $45-$50/hr depending on experience
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