Senior 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 but not limited to 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, 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 writing projects from planning and coordination to submission, including establishing timelines and tracking progress • 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 degree and 7 to 10+ years of industry experience required, advanced degree in science or medical field is a plus • Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules • Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities • Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs • At least 8 years of experience as a regulatory writer in biotechnology or equivalent.