Senior Specialist or Manager, Evidence Generation Force 2, Evidence Solution, Medical Excellence & Operations

📋 Description

• Work as a study manager according to GPSP/GCP and SOP
• Co-development of Risk Management Plan with Pharmacovigilance
• Develop study protocols for reg-PMOS and obtain AbbVie Global Review committee approval
• Co-develop study protocols for non-regulatory non-interventional studies with Medical Affairs
• Develop study-related materials
• Plan, execute and manage studies including feasibility, budgeting, and risk

🎯 Requirements

• Knowledge of GCP, GPSP and Ethical Guidelines for Medical and Health Research Involving Human
• Experience in reg-PMOS protocol development (Manager level)
• Business level English (TOEIC 750+ for Senior Specialist, Versant 42+ for Manager)
• Good communication skills
• Knowledge of statistical analysis is preferred

🎁 Benefits

• Essential Document archiving