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Senior Regulatory Writer
3 months ago
Job Opportunity: Senior Regulatory Writer - Remote
About Us: Join our dynamic midsize Contract Research Organization (CRO) specializing in data-centric areas of clinical trials to stay ahead in regulatory writing and biometrics. We are looking for a skilled Senior Regulatory Writer to help deliver exceptional regulatory solutions.
Role Overview: As a Senior Regulatory Writer, you will play a crucial role in our regulatory writing department, creating various documentation and collaborating with stakeholders. You will be in charge of developing regulatory documents to meet regulatory requirements and industry standards.
Key Responsibilities:
- Regulatory Document Leadership: Lead the creation of top-quality regulatory documents, such as clinical study reports, investigator brochures, protocols, IBs, and regulatory submissions.
- Technical Proficiency: Display a profound understanding of scientific and clinical data, simplifying complex information into compliant documents. Keep updated on regulatory guidelines to incorporate industry standards.
- Cross-functional Collaboration: Work seamlessly with biometrics and other teams to integrate statistical and data management aspects into regulatory documents.
- Quality Assurance: Enforce strict quality control measures to ensure accuracy, consistency, and compliance throughout the document creation process.
Qualifications and Experience:
- Advanced degree in a scientific or related field.
- Extensive experience in regulatory writing at a CRO, focusing on biometrics.
- Thorough knowledge of regulatory guidelines and requirements.
Technical Skills:
- Proficient in interpreting and integrating data into regulatory documents.
- Familiar with statistical concepts and data visualization.
- Expertise in utilizing software tools for document creation and collaboration.
Remote Working Conditions:
- Enjoy the flexibility of working remotely, using advanced communication technologies for effective team collaboration.
How to Apply: Please apply directly through this advertisement.
