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Posted June 15, 2022

Contract Associate Technical Writer – Genentech

Location:

South San Francisco, CA

Description:

Description:
Interested in applying your writing skills in addition to editing? Join a small, close-knit, expert team of technical writers to author and produce regulatory documents for submission to regulatory authorities such as the FDA. Includes authoring complex CMC sections of BLA, pre-meeting packages, and other regulatory documents. Working with some guidance, the Associate Technical Writer takes accountability for timely delivery of clear and concise documents; working effectively and closely with scientists, regulatory personnel, and company leaders; and applying regulatory standards such as the use of model documents, storyboards, and style guides.

Responsibilities:
• Manages the preparation of a suite of regulatory documents
• Works with content owners and project teams to ensure that key information is clearly described.
• Creates and tracks timelines for the production of assigned documents according to filing timelines
• Identifies opportunities for systems or tools to be used for compliant transfer of figures, tables and other content into regulatory documents
• Provide exceptional customer service, technical support, and business services to customers and partners within the technical scientific and regulatory departments

Experience, Knowledge, Skills
• Demonstrated clear, high-quality scientific writing style in the English language
• Experience in regulatory affairs and/or biotech CMC development functions preferred
• Experience of authoring and/or editing regulatory documentation preferred.
• Project management skills: consistently achieves multiple tasks and goals on-time
• Ability to work effectively in a team environment, establishes strong collaborative relationships, resolves conflict by creating an atmosphere of openness and trust
• Self-starter. Must possess excellent business acumen, solid judgement, and able to work autonomously from established goals and strategic direction
• Able to handle multiple priorities, conflicts, and ambiguity

Education: Undergrad or graduate degree, or prior technical writing experience
Location: Genentech South San Francisco campus (on-site work required)
Length of contract: 2 years
Starts: Immediately

To Apply:

parthur@gene.com

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