Deskripsi Pekerjaan
Informasi lengkap tentang posisi dan persyaratan
Ringkasan Yukerja
Lowongan ????????????????????? di Parexel kami kurasi dari Himalayas (kategori Kesehatan). Posisi ini ditandai sebagai remote — pastikan timezone dan syarat lokasi kandidat di deskripsi resmi. Yukerja.com bukan pemberi kerja — lamaran diproses di situs sumber resmi.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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??????????????????(???70%)???????????????????????????PMDA???J-NDA?????????????????
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????: ??????
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1. Regulatory Strategy(??????)
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2. PMDA??
PMDA?????????????(Briefing Document?????????????)
PMDA????????(??????????????)
PMDA?????????????????
3. J-NDA????
J-NDA dossier???????(CTD Module 2.5/2.7?Module 1?)
eCTD???????
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4. ????????
?????????????????????(??)
??????????????(Medical Writing????eCTD?)???
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5. ????????
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1.??????????
NDA???????
CTD????(Module 2.5/2.7)
PMDA???????(????????)
2.???????????
?????????????
CTD????(??????)
?????????
3.????????????
PMDA??????????
CTD???????????????
NDA??????????????
4. CRO??Medical Writing??
CTD????(Module 2.5/2.7?CSR?IB)
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Originally posted on Himalayas