Develop Japanese package inserts (Japanese PI) based on Japanese target label and collaborate with Global Labeling and/or CDT on creation/revision of Japanese PI proactively
Job Summary
Develop Japanese package inserts (Japanese PI) based on Japanese target label and collaborate with Global Labeling and/or CDT on creation/revision of Japanese PI proactively.
Run the Japan Labeling Working Group process and participate in these groups, explaining labeling positions on proposed labeling at the Japan Labeling Committee.
Maintain Japanese PI in post-approval environment and negotiate Japanese labeling of Marketed products with HA, ensuring alignment with global strategy.
Matching Summary
Develop Japanese package inserts (Japanese PI) based on Japanese target label and collaborate with Global Labeling and/or CDT on creation/revision of Japanese PI proactively.
Skills & Requirements
Must-have
Develop Japanese package inserts
Run Japan Labeling committee process
Collaborate with Global Labeling
Maintain Japanese PI post-approval
Negotiate Japanese labeling with HA
Good verbal and written communication
Nice-to-have
Detail-oriented
Problem solving
Process oriented
Quality assurance
Regulatory compliance
Risk assessments
Key Requirements
Minimum 3 years pharmaceutical industry experience
Bachelor degree in scientific discipline preferred
TOEIC score over 700
Good verbal and written communication skills in Japanese/English