Senior Regulatory Document Specialist

3 days ago

alwar, India beBeeRegulatory Full time

Regulatory Medical WriterThis role involves drafting, reviewing, and finalizing regulatory documents such as clinical study reports, investigator brochures, and other essential documents.Familiarity with regulatory document preparation and ability to interpret clinical and scientific data.Strong understanding of clinical study designs, statistical principles, and regulatory guidelines.Excellent organizational skills, attention to detail, and ability to meet deadlines.Detailed job description: This position is responsible for creating, reviewing, and finalizing various regulatory documents including clinical study reports, investigator brochures, and other crucial documents. Key responsibilities involve conducting literature reviews, adhering to regulatory standards, collaborating with cross-functional teams, and ensuring the accuracy and quality of scientific communication.Required Skills:Familiarity with regulatory document preparation and interpretation of clinical and scientific data.In-depth understanding of clinical study designs, statistical principles, and regulatory guidelines such as ICH-GCP and FDA/EMA standards.Superior organizational skills, attention to detail, and ability to manage multiple tasks and meet deadlines.

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    alwar, India beBeeregulatory Full time

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    alwar, India beBeeMedicalWriter Full time

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    alwar, India beBeeRegulatory Full time

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