Medical Writer

3 days ago


Hyderabad, India ValueLabs 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.

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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