Regulatory writer

4 days ago

Ahmedabad, India Veeda Lifesciences Full time

Position : Report Writer Department : Biopharmaceutics Department Minimum Experience Required : 3-5 Years Qualification : B. Pharm/M. Pharm/Pharm D Key Responsibilities Prepare and review Clinical Study Reports (CSRs) for Bioequivalence and Phase 1 studies in compliance with global regulatory guidelines, internal SOPs, and client requirements. Analyze and interpret clinical and statistical data with a clear understanding of study results. subject safety narratives and ensure accurate and timely compilation of final CSR packages. Ensure all documents adhere to standards of grammar, formatting, structure, and consistency. Prepare regulatory-compliant appendices for e CTD submissions, including relevant modules. Collaborate closely with cross-functional teams including Data Management, Bioanalytical, Biostatistics, Regulatory Affairs, and Clinical Operations. Maintain effective communication. Apply strong working knowledge of ICH, FDA, EMA, and other relevant regulatory guidelines. Demonstrate excellent written communication skills.

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    Ahmedabad, India Veeda Lifesciences Full time

    Position : Report Writer Department : Biopharmaceutics Department Minimum Experience Required : 3-5 Years Qualification : B. Pharm/M. Pharm/Pharm D Key Responsibilities Prepare and review Clinical Study Reports (CSRs) for Bioequivalence and Phase 1 studies in compliance with global regulatory guidelines, internal SOPs, and client requirements. ...

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    14 hours ago

    Ahmedabad, India Veeda Lifesciences Full time

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    3 weeks ago

    Ahmedabad, India Veeda Lifesciences Full time

    Position : Report WriterDepartment : Biopharmaceutics DepartmentMinimum Experience Required : 3-5 YearsQualification : B.Pharm/M.Pharm/Pharm DKey ResponsibilitiesPrepare and review Clinical Study Reports (CSRs) for Bioequivalence and Phase 1 studies in compliance with global regulatory guidelines, internal SOPs, and client requirements.Analyze and...

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    3 weeks ago

    Ahmedabad, India Veeda Lifesciences Full time

    Position : Report Writer Department : Biopharmaceutics Department Minimum Experience Required : 3-5 Years Qualification : B.Pharm/M.Pharm/Pharm D Key Responsibilities Prepare and review Clinical Study Reports (CSRs) for Bioequivalence and Phase 1 studies in compliance with global regulatory guidelines, internal SOPs, and client requirements. Analyze and...

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    2 weeks ago

    Ahmedabad, India Veeda Lifesciences Full time

    Position : Report Writer Department : Biopharmaceutics Department Minimum Experience Required : 3-5 Years Qualification : B.Pharm/M.Pharm/Pharm D Key Responsibilities Prepare and review Clinical Study Reports (CSRs) for Bioequivalence and Phase 1 studies in compliance with global regulatory guidelines, internal SOPs, and client requirements. Analyze and...

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    2 weeks ago

    Ahmedabad, India Veeda Lifesciences Full time

    Position : Report Writer Department : Biopharmaceutics Department Minimum Experience Required : 3-5 Years Qualification : B.Pharm/M.Pharm/Pharm D Key Responsibilities Prepare and review Clinical Study Reports (CSRs) for Bioequivalence and Phase 1 studies in compliance with global regulatory guidelines, internal SOPs, and client requirements. Analyze and...

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    3 weeks ago

    Ahmedabad, India Veeda Lifesciences Full time

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    3 weeks ago

    Ahmedabad, India Veeda Lifesciences Full time

    Position : Report WriterDepartment : Biopharmaceutics DepartmentMinimum Experience Required : 3-5 YearsQualification : B.Pharm/M.Pharm/Pharm DKey ResponsibilitiesPrepare and review Clinical Study Reports (CSRs) for Bioequivalence and Phase 1 studies in compliance with global regulatory guidelines, internal SOPs, and client requirements.Analyze and interpret...