Wide and rich experience of 13 years as a Medical Writer and Scientific Document Reviewer with Key industrial players. Circuitous and Compendious Manager performing Operational and technical aspects of

1. Medical Writing, 
2. Global Labelling (CDS, SmPC, USPI, CPM, GPI, CSI)
3. Quality Control
4. Clinical Research
5. Regulatory Intelligence (RI) and Information Management System (RIMS)
6. Solution Support

• Expert in handling Medical writing (MW) and core data sheet (CDS) projects and Project lead who managed 100+ documents
• End to end support for QC initiation through completion of various Regulatory documents
• Primary QC support for periodic safety documents (PSUR, PADER, PBRER, SUSAR, SAR) for one of the best 10 listed pharmaceutical company
• Collaborated with doctors, research scientists, and other subject matter experts (SMEs) for Clinical Protocol (Phase 1 and 3), CRF, PIS-ICF, IB, Modules such 2.4, 2.5, 2.6, 4, and 5 for dossiers preparation
• Managing pharmacological issues related to ROW submissions
• Co-coordinated Clinical Research Coordinators (CRCs) for Clinical Research Trial Programs
• Supervising progress of projects in compliance with quality standards, SOPs, ICH, and other guidelines
• Experienced in CDS system and CDS Compliance tracking Involved in processes conducted in a clinical trial site with coordinators like volunteer selection, ICF collection, Feasibility Questioner Filing, CRF filling