Global Labeling Systems Leader - GxP, SDLC, IT

Merck & Co.

Rahway (NJ)

Hybrid

USD 130,000 - 180,000

Full time

10 days ago

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Job summary

Merck & Co. in Rahway, NJ is seeking a senior leader to manage and guide Business Analysts for complex data analytics applications in a highly regulated environment. You will drive system development, maintenance and monitoring while aligning IT partners with Global Labeling business needs.

The role requires 10+ years in Pharmaceutical Regulatory Affairs Operations, with strong SDLC and GxP expertise. You will lead cross-functional teams, contribute to process improvements, and ensure audit

Qualifications

BS/BA in science, engineering, IT or related discipline with functional working experience in System Development/Management within GxP regulated areas preferred.
Requires 10+ years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and Digital Enablement experience strongly preferred, and applied knowledge of SDLC and IT System/Business System Management.
Candidate must be proficient with IT system and business process support, preferably in the Regulatory or Labeling Management space with general understanding of Label Update process.
Must have experience with audit/inspection facing support for GxP systems and ability to communicate complex concepts in high pressure situations.
Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives.
Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information.
Effortlessly works in a collaborative manner with cross-functional and cross-regional users and stakeholders while building strong working relationships.
Effective communication skills (verbal and written).
Ability to work cooperatively with others and provide significant contributions as a member of a team in addition to serving in a leadership capacity.
Strong organizational skills.
Process-oriented and proficient with GxP (GMP) requirements with experience working in a highly regulated industry.
Experience with business process mapping and system design for workflow management is an asset.
Strong aptitude for authoring Technical Guidance documentation such as User Guidance and SOPs and change control management is required.
Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications.

Responsibilities

Manage and lead Business Analysts for complex data analytics application.
Lead System Development, Maintenance, Enhancement and System Monitoring related initiatives.
Serve as a liaison between Global Labeling Business Users and IT Partners for defining Business Requirements and ensuring system alignment with business needs.
Facilitate System Operations Meetings to resolve issues and manage priorities to protect delivery timelines.
Lead development of User facing System Resources; collaborate with Global Labeling, System Support, IT and Learning to meet delivery timelines.
Lead System Releases with IT Business Partners: Requirements, Documentation, Testing, Implementation, Deployment and Hypercare.
Oversee System Support Model including monitoring cases, root cause investigations, CAPAs and communication.
Conduct System Administrator activities aligning Global processes with System capabilities cross-functionally.
Facilitate Global User Group Forums, release communications and program updates as requested.