Amgen Medical Information Manager in Tokyo, Japan
Adhere to the provisions of laws and regulations, SOPs, and industrial rules.
Provide unbiased and appropriate medical and pharmaceutical information.
Create materials and performs version control of the materials.
Kusuri-no-shiori (drug information sheets)
FAQ and Medical Information Letters
Properly handle copyrighted scientific literatures
Determine whether on- or off-label use is discussed in scientific literature based on the standards.
Train customer service operators.
Capture and analyze customer insights and share them with relevant departments.
Collaborate with Med Info colleagues and promote standardization of operating procedures. Contribute to develop, maintain and improve operating procedures without deviations. In case operating procedures are deviated, the Medical Information Manager undertakes a role in performing and improving corrective and preventive actions diligently and without delay.
Undertake the role of ensuring the quality of work related to inquiry handling (product- and company-related inquiries), material preparation (Interview Forms, kusuri-no-shiori, etc.), and FAQ preparation.
Undertake the role of assuring the quality of the Japanese translation of global contents.
Undertake the role of ensuring the quality of customer support by providing customer service operators with product-related training.
Communication skill required to smoothly inform internal and external customers and stakeholders of his/her intentions and objectives, and obtain their approval.
Ability to present collaborative and problem-solving suggestions and solutions within or outside of the team, based on mutual trust.
Ability to foresee potential needs and risks and formulate countermeasures by capturing customer insights through inquiry handling.
Japanese language skill: Medical writing skills required for medical information-related materials and inquiry handling (as well as the logical thinking skills required for formulating documents).
English language skill: Ability to comprehend scientific literature and general administrative documents.
English language skill: Ability to verify, explain, and persuade the US Headquarters and persons assigned to local offices worldwide about basic and assigned work through e-mail communication/ video conferences.
Basic Qualifications & Knowledge
Bachelor or master degree in pharmacy or life sciences plus at least 3 years of medical information-related work experience (e.g.: Medical Advisor in Medical Affairs, Pharmacovigilance)
Ability to determine on- or off-label use based on the package insert.
Ability to prepare and manage Interview Forms and FAQs.
Experience in reviewing promotional materials, Proper Use Guide, and commentaries on Precautions for Use.
Ability to create and manage a literature database for assigned therapeutic area.
Master of Science degree or higher degree in pharmacy or the life sciences.
At least 5 years of medical information-related work experience.