REMS Operations Specialist

As the Risk Evaluation and Mitigation Strategy (REMS) Operations Specialist, you will support REMS operations, compliance, and project management, ensuring effective communication, resource planning, third-party management, and continuous improvement under the oversight of the US Medical Lead, Risk Mitigation Strategy.

Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

• Support day-to-day REMS operations, including developing communications and agendas, scheduling and facilitating meetings, creating and distributing meeting minutes, driving timely action execution, and ensuring compliance.

• Identify and recommend program and process improvement opportunities.

• Engage with the REMS Administrator and internal cross-functional teams to support effective management of the REMS program.

• Support REMS compliance tracking and audit activities.

• Assist with robust FDA inspection readiness planning, including documentation maintenance, mock inspections, and on-site logistics.

• Conduct project resource planning, track resources, provide deliverables to key stakeholders, and manage reviews and approvals.

• Ensure proactive and timely communication with internal stakeholders.

• Coordinate and participate in ad-hoc operational or strategic projects and assignments as needed.

• Manage third-party outsourcing for REMS activities, ensuring adherence to contracting governance and third-party oversight plans.

• Lead budget tracking, including invoice review and approval.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree

• 1 or more years Pharmaceutical company experience or in an equivalent highly regulated environment

• Experience in process management, operations, and budget management

• Experience working in large matrix organization

• Experience in leading, managing and working with internal cross-functional teams

• Experience in managing multiple projects simultaneously, maintaining trackers, and stakeholder management of project status , risk management and troubleshooting issues impacting timelines or deliverables

• Experience in Smartsheet + basic Microsoft 365 (Outlook, OneNote, Teams, Office)

• Experience interacting with cross-functional business partners in a highly matrixed environment

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Prior Medical Affairs experience

• Ability to lead cross functional teams without authority

• Additional Project Management Certifications

• Expertise in organizational, planning, and business acumen skills

• Proven team player with strong interpersonal skills and leadership abilities

• Understanding of highly matrixed and organizational functions

• Understanding of US Medical Affairs ways of working preferred

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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