Regulatory Writer and/or Regulatory QC/ Editor at Vir Biotechnology

, , United States -

Full Time

Start Date

Immediate

Expiry Date

23 Sep, 26

Salary

120.0

Posted On

25 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Writing, Quality Control, Copyediting, eCTD, ICH Guidelines, Clinical Study Reports, Investigator Brochures, Veeva Vault, SmartSheet, AMA Manual of Style, Project Management, Technical Writing

Industry

Biotechnology Research

Description

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. 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. THE OPPORTUNITY Vir Biotechnology is looking for a Regulatory Writer (Temporary) who will support the quality, consistency, and accuracy of regulatory documents produced by the Regulatory Writing team by either functioning as a support author and/or by focusing on editorial and QC review of documents written by other team members. 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. WHAT YOU'LL DO 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; identify required source documents/data and ensure availability prior to QC start 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 Proofread and copyedit text to ensure clarity, grammar, spelling, punctuation, and consistency of messaging/presentation, while preserving scientific and regulatory accuracy 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 Communicate QC findings clearly and constructively to medical writers and other stakeholders; 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. Communicate status and progress to stakeholders, participating in cross-functional meetings when needed Contribute to the continuous improvement of QC tools, checklists, and processes; provide feedback on SOPs, work instructions, and best practices for regulatory document quality WHO YOU ARE AND WHAT YOU BRING Bachelor’s degree and 5 plus years of relevant experience. Advanced degree in science or medical field is a plus Working knowledge of the industry and content of key eCTD documents, familiarity with CTD/eCTD structure and common templates Understanding of drug development and regulatory submission processes, including familiarity with ICH guidelines and major health authority expectations (eg, FDA, EMA) 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 working cross‑functionally in collaborative team environments and building effective working relationships with authors, reviewers, and project teams Experience with electronic document management and publishing systems (eg, Veeva Vault) Experience with project and timeline management systems (eg, SmartSheet) #LI-AS1 #LI-Remote WHO WE ARE AND WHAT WE OFFER 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. Candidate Privacy Notice

Responsibilities

The role involves writing and editing regulatory documents such as protocols, IBs, and CSRs while ensuring accuracy and consistency. It also requires performing independent QC reviews and collaborating with cross-functional stakeholders to prepare global regulatory submissions.