Medical Writer
3 weeks ago
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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