Sr Associate Medical Information

Career Category

Job 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 Amgens 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 Amgens 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 Amgens global standards.

Basic Qualifications

• Bachelors 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

• Masters degree or higher degree in pharmacy or life sciences.
• At least 3 years of Medical Information-related work experience.