Global Labeling Systems Lead - Regulatory IT

Merck; Rahway (NJ); Hybrid; USD 150,000 - 230,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Merck in Rahway, NJ is seeking a full-time Business System Associate Director for Labeling Operations within GRACS Regulatory Innovation & Information Management. The role leads analysts, drives system development, and partners with IT to ensure regulatory labeling systems meet business needs.

Required are a BS/BA in science or IT-related field and 10+ years in Pharmaceutical Regulatory Affairs Operations with labeling and SDLC experience.

Qualifications

• Requires 10+ years of experience with Pharmaceutical Regulatory Affairs Operations and Labeling Process/ Digital Enablement
• Proficient with IT system and business process support in Regulatory or Labeling Management space
• Experience with audit/inspection facing support for GxP systems and ability to communicate complex concepts

Responsibilities

• Lead and manage Business Analysts for complex data analytics applications
• Oversee System Development, Maintenance, Enhancements and Monitoring
• Serve as liaison between Global Labeling Users and IT Partners to define requirements
• Coordinate System Releases including requirements, testing, deployment and hypercare
• Develop User facing System Resources and ensure alignment with current system version
• Lead and oversee Global System Support Model to reduce compliance risk and improve efficiency
• Support System Administrator activities aligning Global processes with System capabilities
• Facilitate Global User Group Forums, release communications and program updates

Skills

Communication

GxP Compliance

GxP Regulations

GxP Validation

Labeling Compliance

Labeling Systems

Label Management

Pharmaceutical Regulatory Affairs

SDLC

SOP

Systems Development

Systems Management

Education

BS/BA in science

IT or related discipline

Job description

Merck in Rahway, NJ is seeking a full-time Business System Associate Director for Labeling Operations within GRACS Regulatory Innovation & Information Management. The role leads analysts, drives system development, and partners with IT to ensure regulatory labeling systems meet business needs.

Required are a BS/BA in science or IT-related field and 10+ years in Pharmaceutical Regulatory Affairs Operations with labeling and SDLC experience.