Your newpany
My client, a global biopharmaceuticalpany with a goal of contributing to healthcare innovation and environmental sustainability and which is focused on improving people’s quality of life, specialising in Oncology, neurology and rare diseases, and has a position available for a Regulatory Medical Writer to join their Non-clinical Submission & Documentation Management team on an initial 12-month contract.Remote12 Month + ContractOutside IR35£75 p/h - £90 p/h
Your new role
As the Regulatory Documentation Scientist (non-clinical scientific writer), you will manage the submission of authored non-clinical 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 that they are reviewed and approved by the appropriate functional groups.
1. Manage the preparation, review, and submission of non-clinical summary documents for both early development and marketing applications
2. Work with regulatory and scientific functions to ensureprehensive and accurate non-clinical dossiers are being submitted to HAs.
3. Work closely with non-clinical project leaders and scientists inposing regulatory submission documents, study reports and other research-related documents.
4. Develop and maintain processes, tools, and guidelines enabling high-quality document production
5. Represent the non-clinical team in global regulatory initiatives and projects focused on process and technology development
What you'll need to succeed
6. You hold a university degree in a life science.
7. You have several years of working experience in scientific writing and editing in a non-clinical, regulatory domain.
8. You have an excellentmand of writing and editing software, with an interest in exploring and integrating new tools and technologies.
9. You build a culture of trust around you and arefortable working with a wide array of stakeholders.
10. You are obsessed with meeting customer needs and thus, high-quality documentation.
11. You take ownership of your work and are proactive in taking action to resolve issues.
12. Unwavering focus, collaborative teamwork and exceptional delivery