Job Description

The Job holder works within the development delivery team manager to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role.

Key Responsibilities

• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• A good understanding of Clinical Trial Directive, DIA TMF Reference Model and CTA/IND submission requirements for multiple countries/submission types
• Responsible for: coordination, development, refinement of the CTA/IND lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures.
• Accountable to the CTA Team Manager for overall work plans, accountable to individual GRLs/TGs for study submission planning & delivery status.
• Accountability for agreed tasks and projects.
• Ensure independent communication, with a range of internal GSK staff, in supporting achievement of the assigned goals.
• Ensure quality of both own and submission team\xe2\x80\x99s work, delivering to agreed timeframes, including compliance with GSK systems and record keeping.
• Provide input to internal processes and written standards.
• To work flexibly to meet constant shifting priorities and timelines

Minimum Level of Job-Related Experience required

• 5 years of relevant experience

Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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