Job description
Job Description: Role: • Preparation and review of Electronic Common Technical Document ( eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols. • Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports. • Drafting and revising pre-clinical summaries. • Quality control of documents for content, uniformity, adherence to ICH/FDA/EMEA or other ap…