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Medical Writer

Medical Writer

2 - 4 years

|

2 Lacs

hyderabad sanathnagar

Posted:22 hours ago| Platform:

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Skills Required

medical writing clinical study reports documentation clinical study protocols investigator brochures pharmacovigilance

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions.

Roles & Responsibilities:

Draft, review, and finalize clinical study protocols, investigator brochures, informed consent forms, and clinical study reports (CSRs).
Prepare regulatory submission documents (CTD modules, IND, NDA, MAA dossiers).
Write manuscripts, abstracts, and posters for publication/presentation.
Ensure compliance with ICH-GCP, FDA, EMA, CDSCO, and other regulatory authority guidelines.
Collaborate with clinical, pharmacovigilance, regulatory, and biostatistics teams.
Perform literature search and develop summaries for safety/efficacy data.
Maintain version control, templates, and documentation standards.

Work Location: Hyderabad (Sanathnagar)

Interview Process: Assessment test, F2F interview.

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Pharmaceuticals

Hyderabad

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