Associate Ii
3 weeks ago
Committed to quality and excellence in compliance and conformance.
- With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned.
- Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets
- Contributes independently and manages own time to meet the timelines.
- Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.
- Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.
- Makes informed decisions on straight cases within guidelines and policies
- Operate in line with internal SOPs and policies
- Escalate any potential compliance issues to management
- Support periodic and ad-hoc system reports to estimate metrics
- Assist in remediation activities
**Qualifications**:
Must-Have
- Bachelor's Degree
- Demonstrated experience
- Proven ability to consistently deliver to time, cost and quality standards
- Operational knowledge of hardware and software tools required for the job
- Excellent organizational skills and attention to detail
- Knowledge of documentation practices
- Fluent in English, verbal and written
Nice-to-Have
- Project Management experience
- Knowledge across multiple therapeutic areas
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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