Job Purpose
This role is primarily responsible for the execution and regulatory compliance of all PMS/RMP study deliverables managed by the Korea PMS team.
It involves development the design and conduct of studies, managing interactions with key internal and external stakeholders, ensuring regulatory compliance, risk management, and guaranteeing the integrity and completeness of research data throughout its evolution and publication.
This role ensures strict compliance with regulatory requirements and conditions for the license approval and indication expansion of all products across all therapeutic areas (TAs) for which GSK Korea holds MAH, including Oncology, General Medicine, Specialty, HIV, and Vaccines.
Key Responsibilities
Responsible for strong management skill of study and CRO resource, understand and operate according to agreed business priorities, regulatory requirements, and internal processes to ensure excellence in the delivery of Korea regulatory mandated PMS/RMP studies.
Responsible for design and conduct of PMS/RMP studies and related regulatory milestones, ensuring quality and adherence to regulations, budgets, and timelines.
Responsible for complying processes and optimizing PMS/RMP study methodologies in line with evolving regulatory
Ensure strict compliance of PMS/RMP study with regulatory requirements for the license approval and indication expansion cases of all products (to be) licensed in Korea, including Oncology, General Medicine, Specialty, HIV, and Vaccines.
Responsible for working with the key stakeholders and cross-functional team to facilitate the conduct of studies and resolve issues that may impact study delivery. Responsible for oversight 3rd party including outsourced resources by controlling training review, risk management, and KPI tracking.
Requirements
Bachelor’s degree in clinical science or related fields.
7 years or more experience in the pharmaceutical industry including clinical operation, PV, regulatory and medical related area.
Demonstrated in-depth knowledge of regulatory requirements and compliance written standards, particularly in the context of PMS and RMP studies. Proficient experience and knowledge to ensure the integrity and completeness of research data throughout its lifecycle and, along with publication experience as a authorship in peer-reviewed journals.
(Preferred) Auditor-related experience, statistical/coding ability, Health authority engagement
*LI-GSK
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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