Associate Director, CMC Technical Writer

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November 9

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Vera Therapeutics, Inc.

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Biotechnology • Pharmaceuticals

Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability.

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Author and review internal documents including protocols, reports, SOPs, deviations, change controls, and manuscripts in support of all CMC functions. • Work closely with the members of the CMC and Regulatory functions to author and review regulatory documents including IND/IMPD/BLA/MAA sections and meeting packages. • Collaborate with CMC, Quality, and Regulatory colleagues to develop story boards for inspections and responses to information requests. • Review external documents from Vera’s supply chain network. • Develop document templates and workflows for technical documents.

🎯 Requirements

• MS in Chemistry, Biochemistry, or related discipline with a minimum of 6+ years or BS in Chemistry, Biochemistry, or related discipline with a minimum of 8+ years of experience in clinical-stage biopharma with a proven technical track record in technical writing supporting CMC for Biologics. • Experience authoring and reviewing a diverse set of technical documents including technical reports, manuscripts, regulatory filings including BLA/MAA across a broad technical background (analytical, process development, manufacturing) • Experience working with contract service providers is a plus. • Effective communication and documentation skills. • Strong attention to detail and organization. • Excellent interpersonal skills and demonstrated ability to work well in a team-oriented environment. • Candidates must be authorized to work in the U.S.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities