Associate Manager- RIM

Major accountabilities:

• With guidance, ensures good data quality of RIM System (s) by monitoring data accuracy and completeness.
• Proactively follows up with relevant people (e.g. COs, RA CMC, HQ RA Managers) to make certain the data is updated and maintained in RIM system (s).
• Collaborates with the RIM team for implementation of new cleaning rules, and corresponding training material
• Support a compliance and quality culture within RA through effective team  work and open communication
• Escalate potential compliance risks as necessary to management as appropriate
• Support implementation of RA systems in collaboration with subject matter experts and IT
• Compile regulatory compliance monitoring reports and follow ups on quality issue.
• Manage deviations/incidents/Quality Events/CAPAs in the appropriate system together with RA groups according to timelines
• Support or lead the preparation of RA for internal global audits as assigned

Key performance indicators:

• Fully compliant portfolio with internal and external regulations and procedures -Adherence to Novartis policy and guidelines -Stakeholder/ project feedback

Minimum Requirements:
Work Experience:

• Cross Cultural Experience.
• Operations Management and Execution.
• Collaborating across boundaries.

Skills:

• Scientific degree in life sciences or equivalent 
• At least 2-3 years professional experience in Regulatory in Pharma or related area
• Strong knowledge of Microsoft Office Suite of applications (excel, power point, share point, OneNote, MS teams, etc.)
• Basic knowledge of the Drug Development Process and regulatory compliance for marketed products and investigational trials
• Capable to quickly learn and understand how to use RA systems
• Good interpersonal and communication skills, both oral and written
• Good analytical skills, ability to produce meaningful reports from RA systems
• Precise and independent working style with a high sense of responsibility and initiative
• Logical and methodical, with attention to details

Languages :

• English.