CMC Technical Writing Consultant
September 7
🔄 Hybrid – Bay Area
Description
• The CMC Technical Writer will be responsible for CMC document writing and review. • This position will work closely with cross-functional teams within CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met. • Author and/or review technical reports as required by CMC staff. • Author, compile, and manage CMC sections of a wide variety of regulatory submissions. • Effectively manage the integrated drafting and reviewing process to meet appropriate timelines. • Ensure that technical reports adhere to appropriate regulatory guidelines. • Organize and maintain document storage to ensure easy access to reports and related documentation.
Requirements
• Minimum of Bachelor's degree in Chemical, and/or, Biological Sciences/relevant discipline. • 3+ years' experience in technical writing for CMC regulatory filings in cell therapies. • Strong working knowledge of full CMC spectrum, including drug substance and drug product manufacturing, stability requirements, analytical and formulation development and GMP manufacturing considerations in general. • Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure. • Demonstrated ability to translate technical information from mixed sources into written information suitable for regulatory authorities. • Excellent verbal/written communication skills; detail/accuracy oriented. • Proven planning and organizational skills and regulatory writing skills. • Ability to work independently in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing demands.
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