Principal Regulatory Writer – Temporary

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Vir Biotechnology, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Vir Biotechnology, Inc. is a company focused on leveraging the potential of the immune system to address critical unmet medical needs and improve patient outcomes. It specializes in the discovery, engineering, and development of antibody-based medicines for viral health challenges such as COVID-19 and Ebola. Vir Biotechnology employs innovative platforms like the next-generation antibody and the PRO-XTEN™ protease-releasable masking technologies. With a therapeutic concentration on infectious diseases like hepatitis B and delta, as well as strategic programs in oncology, Vir is committed to advancing medical science and delivering transformative medicines efficiently. The company is supported by an experienced leadership team proficient in progressing product candidates through various stages of research to commercialization.

📋 Description

• 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.

🎯 Requirements

• Bachelor’s and 15 to 20 years of relevant experience required. Advanced degree in science or medical field is a plus • Experience with all common study-level and submission-level regulatory documents such as CSRs, IBs, DSURs, protocols, and eCTD modules required • Proven experience with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents) including responses to health authorities, 90/120-day safety updates, or other post-submission activities required • Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs • Proven ability to manage complex projects and influence cross-functional teams.