Associate Director, Business System Labeling Mgt. - Regulatory Affairs
Merck
Summary
Join the GRACS Regulatory Innovation & Information Management organization as Associate Director, Business System Labeling Management, and help shape how Global Labeling works with the systems that power it. This is a team-first environment where collaboration across functions, regions, and time zones is part of everyday work, and where leaders succeed by bringing others along. Continuous learning is expected and supported. Our systems, processes, and regulatory landscape keep evolving, and so do we. You will bring the technical aptitude to own GxP business systems from requirements through release and hyper care, and the judgment to turn complex business needs into clear direction for Business Analysts, IT partners, and users. Above all, we are looking for someone with a “how can we” attitude, who meets competing priorities and tight timelines by finding the path forward rather than the reason to stop.
Job description
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
- 10+ years of experience in Pharmaceutical Regulatory Affairs Operations
- Demonstrated end-to-end ownership and management of GxP business systems (system lifecycle, release management, change control, and operational support)
- Applied knowledge of SDLC
- BS/BA in science, engineering, IT or related discipline
- Proficient with IT system and business process support
- Experience with audit/inspection facing support for GxP systems
- Ability to communicate complex concepts in high pressure situations
- Analytical and process minded with a short learning curve
- Strong leadership and problem-solving skills
- Ability to gather relevant facts and distill information
- Collaborative manner with cross-functional and cross-regional users and stakeholders
- Effective communication skills (verbal and written)
- Strong organizational skills
- Flexibility to handle multiple tasks under pressure across Global Time zones
- Strong attention to detail
- Process-oriented and proficient with GxP (GMP) requirements
- Experience working in a highly regulated industry
- Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP)
- Change control management
- Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications
- Audit Readiness
- Business Requirements Management
- Business Systems Management
- GxP Regulations
- Regulatory Affairs Management
- Regulatory Compliance
- Regulatory Labeling
- Regulatory Operations
- System Development Life Cycle (SDLC) Documentation
- Systems Development Lifecycle (SDLC)
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Retirement benefits
- 401(k)
- Paid holidays
- Vacation
- Sick days
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.