Medicinal Product Data Management Specialist

Performs EVMPD maintenance coordination through data entry and data QC for EVMPD

Maintains understanding of the assigned EVMPD Processes

Manages daily workload and independently addresses questions for assigned regulatory processes

Contributes to enhancements in developed areas of expertise

Provides support for internal audits, HA inspections and corrective action plans.

Supports management in developed areas of expertise

Recognizes and reports data compliance issues and how they impact assigned processes

Executes operational aspects of enabled processes according to BMS procedures

Qualifications Experience
BA/BS degree, science / technology field preferred

1-2 years of pharmaceutical experience

Experience with the life cycle of marketed products (preferred, but drug development experience will also be considered) processes.

Solid regulatory knowledge and previous experience in the Regulatory Information Management area

Demonstrate experience and understanding of the procedures and decision-making process of Health Authorities as it relates to RIM.

Clear knowledge and experience with EVMPD

Possesses knowledge in standard desktop applications and RIM systems, including effective troubleshooting skills.

Easily adapts to new software and procedures.

Strong attention to detail.

Demonstrated ability to follow specific and standards and processes.