Medical Writer

3 days ago

Hyderabad, India ValueLabs Full time

Job descriptionThe Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions.Experience : 1+ yearsLocation : 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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