Medical Writer – Regulatory, IND, CTA, NDA, MAA, BLA

1 week ago

Hertfordshire, United Kingdom hays-gcj-v4-pd-online Remote Work Freelance Full time

Your newpany My client is a global biopharmaceuticalpany with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people’s quality of life, specialising in Oncology, neurology, rare diseases, ophthalmology and immunology. There is an opportunity for a Regulatory Documentation Writer to join their Nonclinical Submission & Documentation Management (NDSM) team.Outside IR35Hybrid / Remote UKYour new role As a highly motivated individual, your primary responsibility as a nonclinical scientific writer, will be to manage the submission of authored nonclinical documents to regulatory agencies in support of applications such as INDs, CTAs, NDAs, MAAs, and BLAs. With your scientific writing capabilities, you will ensure that the documents are clearly written, accurate and consistent, adhere to thepany’s and ICH standards, and are reviewed and approved by the appropriate functional groups.In this position, you will:Manage the preparation, review, and submission of nonclinical summary documents for both early development and marketing applicationsWork with regulatory and scientific functions to ensureprehensive and accurate nonclinical dossiers are being submitted to HAs.Work closely with nonclinical project leaders and scientists inposing regulatory submission documents, study reports and other research-related documents.Develop and maintain processes, tools, and guidelines enabling high-quality document productionRepresent the nonclinical team in global regulatory initiatives and projects focused on process and technology developmentWhat you'll need to succeed Hold a university degree in a life science.Have several years of working experience in scientific writing and editing in a nonclinical, regulatory domain, ideally within Pharma.Have an excellentmand of writing and editing software, with an interest in exploring and integrating new tools and technologies.Take ownership of your work and are proactive in taking action to resolve issues.

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