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Ranit Das

@ranitdas1

Medical Writer at PHARMALEX India Pvt. Ltd., drafting regulatory dossiers, clinical study reports, and investigator brochures.

India

Message

At PHARMALEX India Pvt. Ltd., I draft regulatory submission dossiers, including Modules 2.4–2.7, Clinical Study Reports, and Investigator’s Brochures. I also perform systematic literature searches.

At APCER Pharma India Ltd., I drafted scientific and clinical trial documents, including manuscripts, abstracts, Real World Evidence study reports, safety narratives, and clinical and non-clinical overviews. My work has drawn on guidelines including ICH GCP and ICH E3.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs Associate

Current

Pharmalex India Pvt. Ltd.

Mar 2021 - Present (5 years 7 months)

Drafting regulatory submission dossiers, clinical study reports, and investigator's brochures. Performing systematic literature searches.

Regulatory Submissions Clinical Study Report (CSR)Investigator Brochures Literature Search

Medical Writer

APCER Pharma India Ltd.

Apr 2018 - Mar 2021 (2 years 11 months)

Drafted scientific and clinical trial documents including slide decks, manuscripts, abstracts, and real-world evidence study reports. Gained knowledge of regulatory guidelines such as ICH GCP and ICH E3.

Medical Writing Clinical Study Report (CSR)Investigator Brochures Safety Narratives ICH GCP ICH E3 Clinical Study Report Awareness

Intern

Albert David Limited

Jan 2015 - Feb 2015 (1 month)

Performed chemical and microbiological analysis of finished goods and raw materials. Conducted in-process quality control tests and prepared standard solutions.

chemical analysis Microbiological Analysis Quality Control Standard Solutions