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

Your new company
My client, a global biopharmaceutical company 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.

Remote

12 Month + Contract

Outside 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 the company's and ICH standards, and that they are reviewed and approved by the appropriate functional groups.

• Manage the preparation, review, and submission of non-clinical summary documents for both early development and marketing applications
• Work with regulatory and scientific functions to ensure comprehensive and accurate non-clinical dossiers are being submitted to HAs.
• Work closely with non-clinical project leaders and scientists in composing regulatory submission documents, study reports and other research-related documents.
• Develop and maintain processes, tools, and guidelines enabling high-quality document production
• Represent the non-clinical team in global regulatory initiatives and projects focused on process and technology development

What you'll need to succeed

• You hold a university degree in a life science.
• You have several years of working experience in scientific writing and editing in a non-clinical, regulatory domain.
• You have an excellent command of writing and editing software, with an interest in exploring and integrating new tools and technologies.
• You build a culture of trust around you and are comfortable working with a wide array of stakeholders.
• You are obsessed with meeting customer needs and thus, high-quality documentation.
• You take ownership of your work and are proactive in taking action to resolve issues.
• Unwavering focus, collaborative teamwork and exceptional delivery

What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed)