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À¯ÀüÀÚÄ¡·á½Å¾à°³¹ßȸ»ç   2023-05-19
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À¯ÀüÀÚ Ä¡·áÁ¦ °³¹ß»ç¾÷°³¹ß
(Business
Development)

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 - Development of corporate strategy

 - R&D strategy and product strategy

 - Building global partnership

 - Business negotiation and transaction

 - Alliance management 

 

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 - °æ·Â : ¹ÙÀÌ¿À/Á¦¾à ºÐ¾ß 5³â ÀÌ»óÀ¸·Î ¿µ¾î ´ÉÅëÀÚ

 

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 - Global BD °æÇèÀÚ

 - Alliance management °æÇèÀÚ

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 - ¼­¿ï ¹ÝÆ÷

À¯ÀüÀÚ Ä¡·áÁ¦ °³¹ßÀÓ»ó/ÀÇÇÐ
(Clinical/ Medical)

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 - Clinical strategy

 - Clinical study design 

 - Clinical study protocol and report

 - CRO selection and clinical study management

 - CTD documentation

 - IND submission and approval

 - Quality audit for clinical operation

 

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 - Çз : ÀÇÇÐ,  ¾àÇÐ Æ÷ÇÔ °ü·Ã Àü°ø

 - °æ·Â : ÀÓ»óÀÇÇÐ ½Ç¹« 5³â ÀÌ»ó

 

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 - Medical doctor

 - ±Û·Î¹ú ÀÓ»ó½ÃÇè °æÇèÀÚ

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 - ¼­¿ï ¹ÝÆ÷

À¯ÀüÀÚ Ä¡·áÁ¦ °³¹ßºñÀÓ»ó
(Non-clinical)

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 - Nonclinical study design

 - CRO contract and study management

 - CTD documentation

 - IND submission and approval

 

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 - Çз : ¼®»ç ÀÌ»ó

 - °æ·Â : ¹ÙÀÌ¿À/Á¦¾à In vivo ºñÀÓ»ó 5³â ÀÌ»ó

 

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 - ¼öÀÇ»ç 

 - ±Û·Î¹ú IND/BLA °æÇè

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 - ¼­¿ï ¹ÝÆ÷

À¯ÀüÀÚ Ä¡·áÁ¦ °³¹ßÀÎÇã°¡
(Regulatory Affairs)

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 - Global regulatory affairs

 - Regulatory meetings and briefing packages

 - Rare disease regulation

 - CTD documentation

 - IND compilation and submission, and approval

 

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 - Çз : ¼®»ç ÀÌ»ó

 - °æ·Â : ¹ÙÀÌ¿À/Á¦¾à ÀÎÇã°¡ 5³â ÀÌ»óÀ¸·Î ¿µ¾î ´ÉÅëÀÚ

 

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 - ±Û·Î¹ú RA °æÇèÀÚ

 - ¿µ¹® CTD documentation Àü¹®°¡
 
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02-6925-3360/010-7751-7100   kim@bbp.co.kr