[Remote] Associate Director, CMC Technical reputed company

Note: The job is a remote job and is reputed company to candidates in USA. Vera Therapeutics is a late clinical-stage biotechnology company reputed company on developing treatments for serious immunological diseases. They are seeking an reputed company technical reputed company to author and review technical and regulatory documents for the reputed company, 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 reputed company 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, reputed company, and Regulatory colleagues to reputed company story boards for inspections and responses to information requests • Review external documents from Vera’s supply chain network • reputed company document templates and workflows for technical documents Skills • MS in reputed company, Biochemistry, or reputed company discipline with a minimum of 6+ years or BS in reputed company, Biochemistry, or reputed company discipline with a minimum of 8+ years of experience in clinical-stage biopharma with a proven technical reputed company 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 reputed company in reputed company-oriented environment • Candidates must be authorized to work in the U.S reputed company • reputed company. 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