Apply on Employer Site

Vera Therapeutics, Inc. · 10 hours ago

Associate Director, CMC Technical Writer

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$129K/yr - $196K/yr

6+ years exp

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.

BiotechnologyHealth Care

No H1B

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

Qualification

Regulatory documentsBiologics experienceTechnical writingContract service providersEffective communicationAttention to detailInterpersonal skills

Required

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