Senior Regulatory Writer - United Kingdom - Vivify Talent

Description

Job Opportunity:
Senior Regulatory Writer - Remote

About Us:

Join our dynamic midsize Contract Research Organization (CRO) where we specialise in data-centric areas of clinical trials ensuring we are at the forefront of regulatory writing and biometrics.

We seek a skilled Senior Regulatory Writer to play a key role in advancing our mission of delivering exceptional regulatory solutions.

Role Overview:

As a Senior Regulatory Writer, you will be a key part of our regulatory writing department, authoring a wide range of documentation and working with liaising with various stakeholders.

You will lead the development of regulatory documents, ensuring alignment with regulatory requirements and industry standards.


Key Responsibilities:

Regulatory Document Leadership:
Spearhead the creation of high-quality regulatory documents, including but not limited to clinical study reports, investigator brochures, protocols, IBs and regulatory submissions

Technical Proficiency:
Demonstrate a deep understanding of scientific and clinical data, translating complex information into coherent and compliant documents. Stay abreast of regulatory guidelines, ensuring the incorporation of the latest industry standards.
Cross-functional Collaboration: Collaborate seamlessly with biometrics and other cross-functional teams to integrate statistical and data management components into regulatory documents

Quality Assurance:
Implement rigorous quality control measures, ensuring accuracy, consistency, and compliance throughout the document development process

Qualifications and Experience:
Advanced degree in a scientific or related discipline.
Extensive experience in regulatory writing within a CRO setting, with a focus on biometrics.
Thorough understanding of regulatory guidelines and requirements.


Technical Skills:
Proficiency in data interpretation and integration into regulatory documents.
Familiarity with statistical concepts and data visualization.
Expertise in using relevant software tools for document creation and collaboration.


Remote Working Conditions:
Enjoy the flexibility of a remote work environment, leveraging advanced communication technologies to collaborate effectively with the team


How to Apply:
Please apply directly through this advert, reach out to Vivify Talent via our website ( or on