Business System Management Associate Director

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

Job Description

Seeking a full-time Business System Associate Director for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.

Key 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 the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs
• Facilitate System Operations Mtgs including discussions to resolve issues and manage competing priorities utilizing proper escalation pathways to ensure limited impact to delivery timelines for workstream activities
• Lead the development of User facing System Resources ensuring supporting materials remain aligned with the current system version. Work collaboratively with stakeholders in Global Labeling, System Support Team, IT and Learning & Development organizations to meet required delivery timelines associated with User Resources
• Lead System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases
• Facilitate and oversee the System Support Model for systems within remit including: Monitor user support cases, ensuring thorough root cause investigations are conducted, CAPAs are detailed and closed effectively and communication is consistently done to reduce instances of recurrence. Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users
• Conduct System Administrator activities supporting the alignment of the Global organizational processes with the System Capability cross-functionally and cross-regionally
• Facilitate System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested

Requirements

• 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
• Facilitate System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested
• Demonstrates strong attention to detail
• 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 Standard Operating Procedures (SOP) and change control management is required
• Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications

Required Skills

Communication, GxP Compliance, GxP Regulations, GxP Validation, Labeling Compliance, Labeling Systems, Label Management, Package Labeling, Pharmaceutical Regulatory Affairs, Software Development Life Cycle (SDLC), Standard Operating Procedure (SOP), Systems Development, Systems Management

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

NA

Job Posting End Date

11/12/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R397766