GRA CMC Operations Support Lead

CSL • King of Prussia, PA

3d

About The Position

The Global Regulatory Affairs CMC – Decision Support Lead is responsible for: Providing comprehensive administrative support to the Head of Global Regulatory Affairs CMC to enable the Head of Global Regulatory Affairs CMC to focus on strategic priorities and organizational leadership. This role requires exceptional attention to detail, strong communication skills, maintaining the highest level of confidentiality, and the ability to manage multiple priorities simultaneously. Providing targeted administrative support to the Global Regulatory Affairs CMC leadership team, ensuring the efficient operation of departmental activities. Tracks departmental business actions, goals, objectives, KPIs, and commitments to internal stakeholders. Supports the Head of Global Regulatory Affairs CMC in department-wide resource planning and forecasting through data-driven resource analysis. Partners with finance, HR, and project managers to support workforce planning, hiring forecasts, and contractor use. This role exercises strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to meet the administrative and operational business needs of the department.

Requirements

• High school diploma or equivalent (minimum); bachelor’s degree in business administration, life sciences, or a related field often preferred. Additional certifications in administration, project management, or relevant software (e.g., Microsoft Office Specialist, CAP) are advantageous.
• Exceptional oral and written communication skills.
• Proven proficiency in using and applying Microsoft Excel, PowerPoint, Word, OneNote, SharePoint, Outlook, Power BI, Teams, Planner, List, SAP Concur, as well as Adobe Acrobat or similar for creating/editing PDFs. Ability to quickly adapt to new software platforms is desirable.
• Committed to the highest standards of confidentiality, compliance, integrity, and adaptability.

Nice To Haves

• Familiarity with the pharma or biotechnological industry, and comfortable working with scientific, drug manufacturing, or regulatory terminology is desired; prior experience working in the pharma or biotechnological industry is preferred.

Responsibilities

• Proactively manage the Head of Global Regulatory Affairs CMC’s calendar and schedule meetings as directed,. Know the manager’s short- and long-term objectives as well as the respective departmental stakeholders to ensure appropriate prioritization of meetings, rescheduling of meetings, and avoidance of meeting conflicts. Proactively rebalance weekly meeting load and secure free time slots for focused work.
• Prepare meeting agendas, take meeting minutes, and track action items to ensure timely follow-up or conslusions. Proactively communicate upcoming due dates and deadlines to the respective departmental colleagues.
• Make travel arrangements for individual and groupd travel, including air and ground transportation, lodging, restaurant reservations, meeting room booking, checking visa requirements, and others.
• Coordinate departmental meetings, events, and workshops, including logistics and materials preparation. Prepare the manager’s expense reports. Prepare and edit correspondences, announcements, presentations, and other documents with the highest degree of accuracy and professionalism.
• Assist in on-boarding of new employess and off-boarding of exiting employees. Prepare welcome and on-boarding materials, arrange office and systems access, coordinate introductions, track on-boarding and training completion progress, update internal directories and organizational charts, and assit with early administrative tasks. Assit in developing administrative project plans, coordinate kick-off activities and recurring meetings, and prepare required resources and systems access. Develop timelines and schedules, trck progress, and proactively communicate any conflicts or delays.
• Support the Global Regulatory Affairs CMC leadership team in scheduling and facilitating recurring departmental meetings (e.g., leadership team meeting, change control review meeting, regulatory commitment review, etc.) and their respective agendas and action/conclusion summaries.
• Manage TeamAssurance platform for the Global Regulatory Affairs CMC organization to enable the leadership team to connect with frontline teams in real time, align daily work with strategic goals, and foster a culture of continuous improvement. Manage entries, reminders and follow-ups. Execute data collections and entries, and prepare and manage dashboards as well as analysis reports using Microsoft’s Power BI. Proactively enhance Power BI user skills and expertise through continuous learning (e.g., online classes).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees