Business System Management Associate Director

Merck & Co.

Upper Gwynedd Township (Montgomery County)

Hybrid

USD 120,000 - 170,000

Full time

10 days ago

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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

Job Description

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