YOUR TASKS AND RESPONSIBILITIES

■Plan the PMS (e.g. protocol, CRF) to submit to PMDA for new products

■Select and manage CROs (e.g. data management, statistical analysis, medical writing, site monitoring) in accordance with GPSP (Good Post-marketing Study Practice) ordinance.

■Prepare training materials relating to DUI and SDUI and train the person in charge of site management (e.g. PMS monitors).

■Set the milestones and manage the progress of DUI, SDUI and Post- marketing clinical trial

■Clean the case data (i.e. query resolution as a part of data management) for re-examination, J-PSUR relating to DUI, SDUI and post- marketing clinical trials

■Prepare documents for re-examination, J-PSUR relating to DUI, SDUI and post-marketing clinical trial

■Create the budget projection/plan and monitor the project budget

■Manage the site-contracting and payment process

■Prepare and update SOPs / supplements relevant with DUI, SDUI and post-marketing clinical trial

■Support junior staff members and supervise contract staffs by providing guidance

WHO YOU ARE

■University Degree or above

■At least 3-5 years experience with Post-Marketing Surveillance in a pharmaceutical company

■Well understand the relevant regulations (e.g. GPSP ordinance)

■Native level in Japanese, business level in English (TOEIC > 730, GBC > 1.8) Excellent oral and written communication skills

■This position requires the employee to work across many functions so strong communication and collaboration skills are essential

HOW TO APPLY

Please apply for the position through our recruiting website with Japanese resume, Japanese working experience and English CV.

Please find other working conditions at our career site, by coping and pasting the following URL on your internet browser.

https://career.bayer.jp/en/working-at-bayer/professionals/treatment

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