Senior Manager, Global Labeling Systems & Analytics

Merck & Co.; Upper Gwynedd Township (Montgomery County); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck & Co. in Montgomery County, PA seeks an experienced IT/Business Analytics leader to manage and lead Business Analysts for complex data analytics applications within GxP regulatory labeling operations.

You will oversee system development, maintenance, enhancements, and cross-functional collaboration with IT partners to align business requirements with compliant systems. The role requires 10+ years in Pharmaceutical Regulatory Affairs Operations, SDLC expertise, and strong leadership.

Qualifications

• BS/BA in science, engineering, IT or related discipline with experience in System Development/Management in GxP areas
• 10+ years in Pharmaceutical Regulatory Affairs Operations with labeling and digital enablement experience preferred
• Proficient with IT system and business process support in Regulatory or Labeling Management
• Experience with audit/inspection support for GxP systems and ability to communicate complex concepts under pressure
• Analytical and process minded with ability to drive results to specified objectives
• Strong leadership, problem solving and cross-functional collaboration skills
• Excellent written and verbal communication; detail oriented and process driven
• Familiarity with SDLC documentation requirements for GxP/GMP applications
• Experience with business process mapping and system design for workflow management
• Knowledge of SOPs and change control management

Responsibilities

• Manage and lead Business Analysts for complex data analytics applications
• Lead System Development, Maintenance, Enhancement and System Monitoring initiatives
• Liaise between Global Labeling Users and IT Partners to define business requirements and ensure systems meet business needs
• Facilitate System Operations meetings and escalate issues to minimize delivery impact
• Lead development of User facing System Resources with Stakeholders to align materials with system version
• Lead System Releases including requirements, documentation, testing, implementation and hypercare
• Oversee System Support Model: monitor cases, root cause investigations, CAPA closure and process improvements
• Conduct System Administrator activities aligning processes with cross-functional/global requirements
• Facilitate Global User Group Forums, Release communications and program updates

Skills

GxP knowledge

Regulatory affairs

SDLC knowledge

Systems thinking

Leadership

Cross-functional collaboration

Documentation

Audit/inspection support

Change control

Attention to detail

Education

BS/BA in science or related field

Tools

Regulatory labeling software

Job description

Merck & Co. in Montgomery County, PA seeks an experienced IT/Business Analytics leader to manage and lead Business Analysts for complex data analytics applications within GxP regulatory labeling operations.

You will oversee system development, maintenance, enhancements, and cross-functional collaboration with IT partners to align business requirements with compliant systems. The role requires 10+ years in Pharmaceutical Regulatory Affairs Operations, SDLC expertise, and strong leadership.