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Senior Project Writer
3 months ago
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.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.
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.
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
