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Associate Director, CMC Technical Writer

Remote

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

 

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position 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.

Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

For this role, the anticipated base pay range is

$129,000 - $196,000 USD

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Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.

 

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Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.

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