プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Akshay P.に依頼

United States

Clinical drug development in oncology, hematology and rare disease. Maintain a vast network of KOLs. leverage patient ad

プロフィール概要

• Actively involved with patient advocacy organizations to leverage patient participation • Train, supervise, mentor clinical and regulatory teams. • Experience in working effectively with cross-functional study conduct partners including R&D, Scientific Communication, and Medical Affairs. • Expert knowledge of the drug development process and regulatory environments in the US, Europe, Latin America and Asia. Fluent in multiple languages. • Observational studies, investigator-initiated studies, real world observational studies, registry studies • Budget preparation, negotiation, deliverables tracking and management. • Experienced in SAE reporting, medical review and coding. • Lead and train pharmacovigilance team • Established track record in negotiating contracts and managing performance with vendors in domestic and ex US trials. • Coordinate research publication activities with multiple KOLs.

専門分野

• ★ Clinical Trials
• ☆ Hematology-Oncology
• ☆ Rare Diseases

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, User Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Big Data Analytics, Data Processing, Data Insights

Product Development Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Concept Development, Prototyping

職務経験

Senior Medical Director, Clinical Development

Epharmasystems

6月 2016 - 現在

学歴

Medical Degree (MD)

James Cook School of Medicine

8月 1996 - 9月 2000

認定資格

• 認定資格の詳細は未入力です。