IND(Investigational New Drug) Specialist (12 Month Contract)
• Planning the best cases scenarios of IND(Investigational New Drug) plans for CTA(Clinical Trial Application) and sharing the IND(Investigational New Drug) strategy with stakeholders.
• Establishment of short & long term detailed CTA(Clinical Trial Application) registration plan and follow up to meet the expected approval timeline
• Maintenance of good relationship with regulatory authority and internal stakeholders.
• Timely and appropriate regulatory update of existing investigational products. Perform notification for change and submission for CMC(Chemistry, Manufacturing and Control) and protocol variation.
• Management of the existing investigational products.
• Support CRA(Clinical Research Associate) team task (ex. Reviewing translation of protocols and ICF(Informed Consent Form)).
• Communication and cooperation with GRA(Global Regulatory Affair) for regulatory requirements.
• Learning about the related regulations and guidelines.
• Pharmacist license
• Has good written and verbal communication skills in English
• Korean language ability is MUST
• RA experience in pharmaceutical companies is preferred but not mandatory
At GlaxoSmithKline (GSK) we are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer. GSK is one of the world's leading research based healthcare companies, with over 100,000 employees in 150 countries across our Pharmaceuticals, Vaccines and Consumer Healthcare business.
We are proud of the difference we make and in 2016, FORTUNE Magazine ranked GSK #1 on its list of companies that are changing the world. The 'Change the World' list recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy. Put simply, our focus is on improving access and affordability of medicines, regardless of where people live or their ability to pay.
GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.
At GSK Pharmaceuticals, we are changing the face of healthcare. We are involved in research, development and manufacturing of medicines for a variety of serious and chronic diseases, with market leading products for; Respiratory; Anti-Viral, Central Nervous System, Cardiovascular and Urogenital; Anti-Bacterial; Oncology; and HIV.
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