Posted Date: May 8 2024
Key Responsibilities
Responsible for regulatory commitment study with complete compliance in entire project progress, specifically data collection, analysis and report writing in line with regulatory requirement.
Ability to develop and manage the key study document aligned with scientific and evidence perspective accordance with written standards and mandatory legislation
To have business ownership of relevant venders by conducting oversight and risk management aligned with GSK ICF(internal control framework) model
Collaborate with team and key stakeholders
Work on any assignment as directed.
Requirements
Minimum BS in science or related medical, bio field (Pharmaceuticals, nursing, biology, epidemiology )
4+ years related experience of project management including outsourced resource management, budget projection, and authority engagement
Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Attention to detail with strategic organization.
Experience working in Pharma/Bio/CRO environment that requires working with practical operators to better understand requirements
Focused on solution thinking and agile in learning new systems and processes
Motivated and interested in learning new study, scientific discussion and research
Ability to communicate both verbally and in writing with all levels both insider and outsider of organization.
The ability to clearly write technical documentation as necessitated by regulatory agencies on internal policy
Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
Sense of urgency, flexibility, and accountability.
Must be a committed team player prepared to work in and embrace a team-based culture.
Ability and motivation to work in new applications, business processes.
Provide expertise necessary to train site personnel.
*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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