Fatima Khalifa M. A. A.Private profile: Upwork shows its earnings only to signed-in members, so we check it every few weeks, not daily. MRR here is a rough estimate (Upwork's six-month earnings ÷ months active). Last read Nov 5, 2026.

I specialize in bridging the gap between high-level clinical trial execution and rigorous regulatory submission readiness. With extensive experience in multi-site clinical operations and advanced quantitative pharmacokinetics, I help global biopharmaceutical sponsors, CROs, and medical institutions build audit-ready data structures and compliant regulatory dossiers for health authorities. My background focuses heavily on the new drug human trials framework, ensuring that complex clinical datasets, protocols, and study reports align seamlessly with FDA, EMA, and ICH-GCP expectations. Core Areas of Regulatory & Operational Expertise: = FDA & Global Regulatory Submission Readiness: Comprehensive support in preparing, auditing, and reviewing critical regulatory documentation for Investigational New Drug (IND) applications and New Drug Application (NDA) packages. Expert in ensuring compliance across Common Technical Document (CTD/eCTD) modules, specifically Module 5 (Clinical Study Reports) and Module 2 (Clinical Summaries). = Clinical Trial Data Governance: Solid experience as a multi-site Clinical Research Associate (CRA), managing methodology compliance, auditing protocols across major health networks, and designing data pipelines that easily withstand stringent regulatory scrutiny. = Pharmacometrics & Model-Informed Drug Development (MIDD), Model-Informed Precision Dosing (MIPD) Frameworks: Highly proficient in translating complex datasets into predictive Model-Informed Drug Development (MIDD) and Model-Informed Precision Dosing (MIPD) workflows. Advanced expertise in population pharmacokinetic (PopPK) nonlinear mixed-effects modeling using NONMEM, PDx-Pop, and R data analytics Why Premium Sponsors & CROs Hire Me: = Award-Winning Clinical Track Record: Published author with 9 peer-reviewed articles in SCI-indexed journals and 2 book chapters. My clinical pharmacokinetic research has won 1st place honors at the American College of Clinical Pharmacy (ACCP) annual symposium and is actively cited within official international clinical guidelines (IDSA). = Clinical Trials Alignment & Trilingual Communication: Operating as a Clinical Trials Specialist for overseas clinical studies, ensuring total familiarity with international operational speeds, timelines, and compliance standards. Trilingual proficiency in Arabic (native), English (C2), and Turkish (C1) allows me to coordinate seamlessly across multinational trial sites and global sponsor teams. I treat regulatory compliance not just as an administrative task, but as a critical strategic milestone toward clinical success and market approval. Let’s discuss how I can streamline your upcoming submission or audit your current trial data pipelines for maximum regulatory compliance. Click "Invite to Job" or "Message" to connect immediately. My skills: Regulatory Submissions FDA Submissions Regulatory Affairs Clinical Trial Protocol Clinical Research GCP (Good Clinical Practice) IND Applications Pharmacokinetics Pharmacodynamics NONMEM R SPSS STATA