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.