More jobs in Tokyo from smaller categories that do not yet have their own section — scored for visa sponsorship, Japanese level, salary and fit.
A clinical planning role in Sumitomo Heavy Industries' Industrial Equipment Division, which manufactures and sells medical devices including BNCT (boron neutron capture therapy) systems, proton therapy systems and PET radiopharmaceutical synthesis equipment. Because BNCT and PET are also assessed against pharmaceutical standards, regulatory filings increasingly require clinical trials, and the division is setting up a new clinical team; this is its first hire, for clinical planning.
The work includes drawing up trial strategies with internal teams and outside pharmaceutical companies, CROs and physicians; planning and reviewing protocols; planning trials under US, Chinese and other Asian regulations; agreeing set-up and schedules with hospitals and key opinion leaders; and handling PMDA consultations on clinical data packages.
Required: clinical development experience for medical devices or pharmaceuticals, PMDA experience in marketing approval applications, understanding of the Pharmaceutical and Medical Device Act, basic medical knowledge, and the ability to find and understand medical literature.
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