Principal Regulatory Writer (Temporary)

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 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