Accountabilities for company compliance management
• To be familiar with the rules in the pharmaceutical industry and advises all departments in business from the viewpoint of legal affairs and compliance.
• Bridging the Global SOP and regional rules to create and update the appropriate SOP
• Catching trends in rule changes at authorities and industry groups promptly and reflect them in the internal SOP.
• Audit and supervise information provision activities for internal and external stakeholders.
• Participate in the in－house approval flow and examine each project from the viewpoint of
• Create a violation prevention program by actively verifying in－house compliance violations.
Perform regular verification, report to management and prevent recurrence by the program.
• Conduct regular compliance training for internal companies and partner companies in collaboration with the internal training department.
• Requesting advice from external advisors for maintaining appropriate compliance within the company.
Medical information management
• Create or review materials appropriate for information provision activities, based on the product material creation rules instructed by Japanese authorities and HQ.
• Be familiar with the information about company product and provide scientific advice to external and internal stakeholders.
• Verify scientific evidence from in－house materials and articles. Reflect appropriate information on sales and medical materials.
• Support Field Medical activities by providing appropriate information for medical activities based on the latest evidence and guidelines announced at academia and societies.
• Support for publication of papers written in－house or by the Investigator.
• Properly provide information according to information required from external stakeholders （Q
＆ A at call center and reception of external complaints regarding information provision activities and their response）.
【歓迎（WANT）】Over 3yrs experience in the pharmaceutical compliance field •
• Familiar with legal rules in the pharmaceutical industry, code of practice, and MHLW guideline for activities of information provision
• Tertiary health/science related qualification
• Outstanding communication, writing, and presentation skills
• Ability to learn and effectively convey clinical and non－clinical information and international
scientific/medical publications information in Japan
• Ability to work in teams and autonomously.
• Strong business acumen