Associate Director, CMC Technical Writer
Vera Therapeutics, Inc.Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
We seek an experienced technical writer to join a highly talented, fast-paced and collaborative team. This position will report to the Executive Director of Analytical Sciences and will author and review technical and regulatory documents for the chemistry, manufacturing and controls (CMC) function. Working with the CMC team along with other functions including Regulatory, Quality Assurance, Project Management, and with external contract service providers, this position will enable complete, accurate, and clear documents to support Vera’s clinical and commercial programs.
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.
Qualifications
- 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.
Skills
- Technical writing for CMC biologics
- Regulatory document preparation (IND/IMPD/BLA/MAA)
- Collaboration with cross-functional teams (CMC, Regulatory, Quality)
- Document templating and workflow development
Education
- MS in Chemistry, Biochemistry, or related discipline or BS in Chemistry, Biochemistry, or related discipline