[Remote] Associate Director, CMC Technical Writer

Note: The job is a remote job and is open to candidates in USA. Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. They are seeking an experienced technical writer to author and review technical and regulatory documents for the chemistry, manufacturing, and controls (CMC) function, collaborating closely with various teams to ensure complete and accurate documentation. Responsibilities • 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 Skills • 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 Company Overview • Vera Therapeutics, Inc. It was founded in 2016, and is headquartered in South San Francisco, California, USA, with a workforce of 201-500 employees. Its website is https://veratx.com/. Apply tot his job Apply To this Job