GRACS Operations, Process & Systems (OPS) Hub Site Lead

MSD; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is looking for a Hub Site Lead for GRACS Operations, responsible for establishing and managing regulatory operations capabilities while ensuring effective collaboration with diverse stakeholders. This leadership role emphasizes a high-performing environment focused on delivery excellence and innovation. The ideal candidate will oversee submission planning and execution activities and serve as the main interface with both local and global teams.

Responsibilities

• Establish and expand local GRACS OPS capabilities.
• Manage Regional Regulatory Operations staff.
• Coordinate submission planning and execution.

Job description

Overview

The GRACS Operations, Process & Systems (OPS) Hub Site Lead role is responsible for (1) establishing and expanding the local GRACS OPS capabilities in coordination with OPS Functional Areas and (2) managing Regional Regulatory Operations staff located at the site execution regulatory operations activities (e.g. submissions planning & execution along with labeling and artwork coordination activities). OPS Site leadership is responsible for ensuring effective coordination of local site activities across all OPS functional areas. The individual will work closely with various OPS functional areas and collaborate with key stakeholders at global, region and headquarters. The Hub Site Lead is responsible for fostering a high-performing, collaborative, and inclusive environment that enables delivery excellence, innovation and efficiency across GRACS OPS Hub functions.

OPS Site Leadership will additionally have direct managerial responsibilities for Regional Regulatory Operations staff located at the hub site. This position will be responsible for executing regulatory operations activities. The role will be involved with assigned operational work e.g. Submission Planning as well as provide local managerial oversight on the execution of Regional Regulatory Operations hub work that encompasses submission planning and execution, and labeling and artwork coordination activities, while serving as the primary interface with internal stakeholders, site-level governance bodies, and functional leaders. The geographical scope of regional regulatory operations activities may support EU & EEMEA, AP or other global capabilities with collaboration across local, regional & global stakeholders as needed.