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. , 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 Principal Regulatory Writer (Temporary) who will support all aspects of regulatory submissions writing needs.

You will collaborate with senior management and other leads to support consistent documents/messaging within and across programs. This Person will report to the Senior Director, Regulatory Writing.

WHAT YOU'LL DO

Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including FDA and EMA 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, internal/external facing labeling documents (eg, CCDS/CCSI, annotated draft labels, IFU, patient leaflets, etc), and components of regulatory submission dossiers (eg, NDA, IND, MAA) such as Module 2 and 5 summary documents (eg, SCS, SCE, ISS, etc) Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards Analyze complex scientific and medical information, including clinical trial data, translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents Provide teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas

WHO YOU ARE

AND WHAT YOU BRING Bachelor’s and 15 to 20 years of relevant experience required.

WHO WE ARE

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WHAT WE OFFER

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Qualifications

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