Vir Biotechnology

Vir Biotechnology

Regulatory Writer and/or Regulatory QC/ Editor

Remote - United States · Contract

No sponsorship$90k-$120kDetected 27 days ago
Project ManagementHRIntellectual PropertyFDA RegulatoryAnimal StudiesBiostatisticsRegulatory Affairs

About the role

  • Reporting to the Senior Director, Regulatory Writing, you will help ensure accuracy, compliance, and consistency of regulatory submission materials by partnering closely with medical writers, regulatory affairs, clinical, biostatistics, and other cross‑functional stakeholders.

Responsibilities

  • In partnership with an experienced lead author, write and edit a wide range of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and components of regulatory submission dossiers (eg, NDA, IND, MAA)
  • Perform independent QC reviews of documents produced by the regulatory writing function
  • Verify the accuracy and internal/external consistency of documents versus their source materials
  • Define and confirm the scope of QC activities with document authors
  • Review documents for adherence to applicable style guides (eg, AMA Manual of Style and internal style/formatting standards), templates, and regulatory guidance, identify and document discrepancies and recommended corrections
  • Support preparation and inspection‑readiness of technical documents for global regulatory submissions (eg, eCTD/CTD), including integration of narrative text, tables, graphs, charts, and statistical output
  • collaborate to resolve issues and support timely completion of deliverables
  • Facilitate the efficient project management of individual document workflows (from KOM through handoff to publishing) and contribute to departmental trackers and integrated timelines.
  • provide feedback on SOPs, work instructions, and best practices for regulatory document quality
  • Contribute to the continuous improvement of QC tools, checklists, and processes; provide feedback on SOPs, work instructions, and best practices for regulatory document quality

Requirements

  • Exceptional attention to detail with strong analytical and critical‑thinking skills, including the ability to identify inconsistencies, data issues, and deviations from standards
  • Proven ability to manage multiple tasks and priorities in a deadline‑driven environment, operating with a high degree of independence and accountability
  • Experience with electronic document management and publishing systems (eg, Veeva Vault)
  • Experience with project and timeline management systems (eg, SmartSheet)
  • identify required source documents/data and ensure availability prior to QC start

Nice to have

  • Bachelor's degree and 5 plus years of relevant experience.

Compensation

  • This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.

Benefits

  • Communicate QC findings clearly and constructively to medical writers and other stakeholders
  • Advanced degree in science or medical field is a plus
  • Understanding of drug development and regulatory submission processes, including familiarity with ICH guidelines and major health authority expectations (eg, FDA, EMA)

Company info

  • The expected hourly range for this position is $90.00 to $120.00.
  • Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
  • Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
  • All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications.
  • Employment decisions are made without regard to any legally protected characteristics.
  • This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
  • Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
  • Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology.
  • Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes.
  • We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
  • For hires based in the United States, Vir Biotechnology, participates in E-Verify.
  • Vir Biotechnology has exclusive rights to the universal PRO-XTEN ® masking platform for oncology and infectious disease.
  • We believe the success of our colleagues drives the success of our mission.
  • We are committed to creating a company where everyone feels supported and encouraged to give their best.

Visa & Work Authorization

  • Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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This listing is sourced directly from Vir Biotechnology's careers page and normalized into a canonical job model.