Provides technical support for operations regarding equipment/system initial validation and requalification within a cGMP-compliant environment.
Compensation
Salary Range: $60,966 - $85,694. Final pay determinations will depend on various factors, including but not limited to experience level, education, knowledge, skills, and abilities.
Responsibilities
Drafts protocols and executes equipment commissioning, qualification, and requalification’s per Standard Operating Procedures (SOPs).
Coordinates and communicates all testing with affected functional groups and evaluates test results.
Analyzes data, composes a final report and circulates for approval.
Executes equipment validation studies to include protocol preparation, scheduling, protocol execution, and final report preparation.
Participates in presentation of results to Regulatory Agency when necessary.
Lead and support clinical development activities for late phase AstraZeneca-sponsored clinical programs, including protocol design, data review, safety monitoring, and regulatory submissions.
Locations (2)
Manyata Tech Park, Bangalore, India
Bangalore, India
Responsibilities
Draft and review clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions
Implement protocols and interact with vendors and CROs
Produce materials for investigator meetings
Triage and address questions regarding scientific and protocol procedures
Serve as contact with vendors and CROs regarding medical/clinical science issues
Requirements
Required Life Sciences degree or equivalent
PharmD with equivalent experience, Ph.D. degree in life sciences, or MD preferred
Nice to have: Oncology experience
Nice to have: Industry or academic experience in drug development
Associate Global Development Scientist Director IAstraZeneca · Manyata Tech Park, India+1 more