Executive – Regulatory Affairs
Sun Pharma
Advertisement
Job Description
Designation: Clinical Research Associate
Company: AstraZeneca
Qualifications: Bachelor of Pharmacy / Master of Pharmacy / Life Sciences
Years of Experience: 0-1 Year
Role & Responsibilities
- Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system.
• As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting
• Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalised
• Initiates and maintains production of study documents, ensuring template and version compliance
• Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List
• Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents
• Manages and coordinates tracking of study materials and equipment
• Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies
• Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations
• Keeps own knowledge of best practices and new relevant developments up to date
• Liaises with compliance team members to improve regulatory processes within the team
• Identifies opportunities to improve the methodology and provide practical solutions for clinical development
Educational Qualification
• Essential: Bachelor’s degree in relevant discipline; Experience of Study Management within a pharmaceutical or clinical background; Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management
• Desirable: Advanced degree within the field; Professional certification; Understanding of multiple aspects within Study Management
Location
Bengaluru
Advertisement
Recent Jobs
Safety Writer
fortrea
Medical Writer, Medical Communications
Cactus Life Sciences
eTMF Operations Analyst
 Bristol Myers Squibb
Associate Patient Data Specialist
Thermo Fisher Scientific
Pharmacovigilance Safety Scientist
Propharma
Statistical Programmer I
Quanticate
CRA (Level I, Level II and Sr CRA)
Thermo Fisher Scientific