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 Regulatory content team.
Outside IR35
Remote UK
Your new role
As a highly motivated individual, your primary responsibility as a Pharmacovigilance / Device writer, will be to be the lead author on documents and manage the submission of regulatory content to regulatory agencies, including the Clinical Dossier and/or Suite of Safety reports for drugs or medical devices. With your scientific writing capabilities, you will ensure that the documents are clearly written, accurate and consistent, adhere to the company's and applicable regulatory guidelines/SOPs.
In this position, you will:
Be the lead author - Regulatory content may include the Clinical Dossier and/or suite of safety reports for drugs or medical devices.
Manage the preparation, review, and submission of regulatory content documents for both early development and marketing applications
Plan content and create timelines for the production and review of documents, ensuring alignment with overall project timelines where appropriate.
Review documents for organisation, clarity, scientific standards, and consistency of content, data, and messaging.Resolves issues with cross-functional contributors.
Ensures compliance with regulatory requirements and internal processes
Actively contribute to best practices and continuous improvement initiatives and projects
May act as a mentor to new or less experienced Content Strategists.
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 regulatory domain, ideally within Pharma.
Must have hands-on writing experience of protocols, PBRERs, DSURs etc and experience with Medical Devices documentation.
Familiar with regional/global drug and device development processes, regulations, and guidelines (e.g., GxP, GCP, ICH, ISO, and MDR/IVDR) and an understanding of GVP and GCP principles, including data integrity.
Excellent administrative and project planning skills, with proficiency in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault; detail-oriented, creative thinker with a curiosity to learn and adapt to change, and fluent in English (verbal and written).
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 (phone number removed)
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