Medical Writer – Regulatory, IND, CTA, NDA, MAA, BLA
JOB_53604014751913Job type
ContractLocation
HertfordshireWorking Pattern
Full-timeSpecialism
Regulatory AffairsIndustry
PharmaceuticalsPay
£50 - £90 p/h Outside IR35
12 m + contract – Consultant Regulatory Documentation Writer -Top Pharma - Outside IR35 - Remote UK
Your new company
My client is a global biopharmaceutical company 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 IR35
Hybrid / Remote UK
Your 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 the company’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 applications
- Work with regulatory and scientific functions to ensure comprehensive and accurate nonclinical dossiers are being submitted to HAs.
- Work closely with nonclinical 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 nonclinical team in global regulatory initiatives and projects focused on process and technology development
What 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 excellent command of writing and editing software, with an interest in exploring and integrating new tools and technologies.
- Comfortable working with a wide array of stakeholders.
- Take ownership of your work and are proactive in taking action to resolve issues.
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 living 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 03330106292
Medical Writer – Regulatory, IND, CTA, NDA, MAA, BLAJOB_536040147519132025-12-022026-03-03
Talk to Roberta Atkins, the specialist consultant managing this position
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JOB_53604014751913