Description
**Responsibilities**
+ Provide balanced, accurate, and scientific medical/pharmaceutical information related to Amgen K.K. products and therapeutic areas (TAs), in response to unsolicited medical inquiries, in compliance with global SOPs and local regulations.
+ Develop, update, and maintain Medical Information materials (e.g., FAQs, Interview Forms, _Kusuri-no-Shiori_ , Data on File, etc.), ensuring appropriate version control.
+ Report adverse events and product complaints related to Amgen K.K. products in accordance with internal procedures.
+ Contribute to the effective management of the Medical Information Call Center to ensure the accurate and consistent provision of information.
+ Support the development and maintenance of Medical Information content and digital communication channels.
+ Identify, analyze, and communicate customer insights obtained from inquiries to relevant internal stakeholders.
+ Ensure all Medical Information activities are conducted in compliance with local regulations, internal procedures, and industry codes.
+ Collaborate with local, regional, and global cross-functional stakeholders as well as external partners to manage and enhance Medical Information operations.
**Key Activities**
+ Manage the following Medical Information operations related to assigned products and therapeutic areas (TAs):
+ **Creation and maintenance of Medical Information materials** , such as Interview Forms, _Kusuri-no-Shiori_ , FAQs, Medical Information Letters, and package insert references and Data on File used in non-promotional materials.
+ **Provide accurate, scientific, and balanced product and TA-related information** in response to inquiries in a timely and compliant manner.
+ **Support vendor management** to ensure the quality and accuracy of responses provided by call center agents and digital channel vendors.
+ **Deliver appropriate training** to outsourced partners based on in-depth knowledge of products, TAs, relevant regulations, industry codes, and Amgen procedures.
+ **Monitor publications** in scientific journals and congresses, and manage literature within the internal database.
+ Understand internal and external customer needs and contribute to developing optimal Medical Information solutions to meet those needs.
+ Understand both Japan and global Medical Information strategies, and contribute to localizing and executing them effectively within Japan.
+ Build and maintain strong relationships with internal (local and global) and external stakeholders to support Amgen’s business objectives.
+ Collaborate closely with Medical Information colleagues to **standardize, maintain, and continuously improve operating procedures** . In case of procedural deviations, work proactively with the Medical Information Manager to implement corrective and preventive actions (CAPA) promptly and effectively.
**Skills**
+ **Excellent communication skills in Japanese** , with the ability to interact effectively and professionally with external customers, partners, vendors, and internal stakeholders.
+ **Basic English communication skills** for internal collaboration within Amgen, including reading, writing, and participating in meetings with English subtitles when necessary.
+ **Customer-oriented mindset** , with the ability to search, evaluate, and summarize medical information to address inquiries accurately and efficiently.
+ **Ability to identify customer needs and potential risks** related to Amgen products and provide appropriate feedback to internal stakeholders.
+ **Strong compliance awareness** , ensuring adherence to relevant regulations, industry codes, and Amgen internal procedures under the supervision of the Medical Information Sr. Manager.
+ **Positive and proactive attitude** , with the ability to work efficiently and align with Amgen’s business priorities.
+ **Language proficiency** :
+ _Japanese_ : Native-level fluency, with excellent verbal and written communication skills to provide clear, polite, and professional information to healthcare professionals.
+ _English_ : Ability to understand scientific literature and administrative documents, and to communicate effectively with global/regional colleagues through written correspondence and online meetings. (TOEIC 600+ preferred)
+ **Basic IT literacy** , including proficiency in internal systems and tools for managing information, developing responses, and generating reports.
+ **Understanding of global and regional Medical Information strategies and directions** to ensure alignment with Amgen’s global standards.
**Basic Qualifications**
+ **Bachelor’s degree** in pharmacy, life sciences, or a related field.
+ **At least 3 years of professional experience** in a Japanese pharmaceutical company or medical information/service provider.
+ **Experience in Medical Information-related roles** within a Japanese pharmaceutical company or a Medical Information service provider is highly preferred.
**Knowledge**
+ **Local guidelines, policies, and regulatory/compliance requirements** , including:
+ Creating Medical Information materials and responses to unsolicited customer inquiries in compliance with applicable regulations.
+ Reviewing promotional materials, Proper Use Guides, and commentaries on Precautions for Use.
+ Understanding of **copyright and intellectual property principles** when developing or providing information.
+ **Therapeutic area (TA) expertise** in at least one of the following fields: Cardiovascular/Metabolic Diseases, Bone Health, Immunology, Neuroscience/Central Nervous System, Oncology/Hematology, or Rare Diseases.
+ **Familiarity with medical information resources and emerging AI-based technologies** for information retrieval and management.
**Preferred Qualifications**
+ Master’s degree or higher degree in pharmacy or life sciences.
+ At least 3 years of Medical Information-related work experience.
