Tier-1 Generics company, under the umbrella of a top-10 foreign big pharma company. They are committed to improving the health of patients in Japan with affordable medicines that are safe, and of the highest quality.
The MHLW in Japan is firmly committed to the generics industry and has clearly indicated that it will continue to encourage the use of safe and effective generics over patented Rx moving forwards.
This is a truly modern and innovative company which has expanded rapidly in the past 10 years and sees very strong growth, despite the competition, in the biologics and biosimilars market in Japan. They have recently attracted significant talent form big pharma and consulting to join their mission.
• Project Management: Review and manage projects and budgets; Manage schedules and prepare status reports as required.
• Leadership: Lead the team in identifying and resolving issues and achieving program goals, including contingency plans.
• Systems: Develops mechanisms for monitoring project progress, involving team members and line managers, and problem solving.
• Collaboration and Teamworking: Work closely and collaboratively with stakeholders and alliance partners to ensure that requirements are met. Communicates with R&D, marketing, manufacturing, and regulatory departments.
• Quality and Consistency: Ensures consistent practices are implemented throughout all stages of the project lifecycle.
• Reporting and Analysis: Prepares technical reports, summaries, protocols, and quantitative analyses.
• Planning: Carry out high-quality, integrated, cross-functional planning of the project.
• Best in Class: Apply best practices in the development, start, planning, execution, management, and completion of projects.
• Pharma or generics operations management experience.
• Project management experience in pharma or generics.
• New product planning experience would be an advantage.
• R&D Portfolio and Project Management.
• Biostatistics experience.
• TQM, knowledge related to GxP standards and processes in related industries
• Finance Management
• Experience of compounds to clinical, pre-clinical and translational medicine stages of clinical research.
• Experience with PMDA/MHLW.
• Experience of regulatory submissions.
• End-to-End pharmaceutical drug development.
• Native level Japanese (or JLPT N1).
• Fluent business English.
• Please note that only current residents of japan are considered for this role.