Shiwangi Desai
Regulatory and Medical Writer |Medical Device| EU MDR| CEP| CER| SSCP| PMS| PMCF| PSUR| ICH-GCP| CSR| Protocol| REF| QMS| IQA| IMDR|
- Role
- Medical Writer-deputy Manager at BD
- Location
- Surat, GJ, IN
- LinkedIn followers
- 500 followers
About Shiwangi Desai
A qualified and experienced healthcare professional with 5+ years of experience into Regulatory and Medical Writing, with overall 11+ years of varied experience including Quality Assurance and Hospital Pharmacy. An efficient communicator, team member and project leader with skills in trouble shooting, planning abilities and resource management with task accomplishing goals. Key areas of expertise include strategizing, planning, developing, writing and reviewing of Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Clinical Study Reports (CSR), protocols, Post Market Surveillance (PMS)/Periodic Safety Update Reports (PSURs), Post-Market Clinical Follow-Up (PMCF), regulatory dossiers/applications and quality management system (ISO 9001 and 13485) documents. Also, a certified internal auditor, have conducted internal audits and faced several external audits as a Management representative.
Experience
Medical Writer-deputy Manager
Feb 2024 — Present
Education
Savitribai Phule Pune University
Bachelor of pharmacy, Pharmacy
2004 — 2008
Sikkim Manipal Institute of Technology
MSc. clinical research and regulatory affairs, clinical research
2008 — 2010
Skills
- Clinical Research
- Clinical Trials
- Ich-Gcp
- Internal Audit
- Regulatory Documentation
- Protocol Writing
- Qms
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