Medical Writer

Job description The Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions. Experience : 1+ years Location : Hyderabad (Work from office) 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.

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