Skills
Core Competencies
•Protocol Writing & Interpretation
•ICF & SIS Development
•Ethics Committee (EC), IRB & Competent Authority Query Handling
•Project & Stakeholder Management
•Mentorship, Training & Knowledge Sharing
Technical Skills
•Microsoft Office
•MS Word | Excel | PowerPoint
•Document QC & Review Tools
•Reference Management Tools
•Literature Review Tools
About
Detail-oriented medical writer with proven expertise in developing and reviewing protocols, informed consent forms (ICFs), and subject information sheets (SIS) for clinical research studies. Experienced in Ethics Committee coordination, with a strong foundation in ICH-GCP, FDA, EMA, and Health Canada guidelines. Adept at managing cross-functional collaboration with sponsors and project managers while ensuring compliance, accuracy, and timely project delivery. Skilled in timeline management and query resolution, with additional experience in mentoring and training junior team members.
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