PMS Planning & Management Head
On-siteTokyo, Tokyo, Japan
Job Summary
Lead a high-performing team to shape post-marketing surveillance strategy and drive regulatory excellence for Sanofi's medicines portfolio in Japan. Design and oversee scientifically appropriate PMS programs, including usage surveys, database studies, and post-marketing clinical trials, while managing negotiations with regulatory authorities and representing the team in conformity inspections. Own the full PMS lifecycle from study outline development to periodic safety reporting, fostering cross-functional collaboration with Development, Medical, Safety, and Commercial teams. Mentor team members to develop talent and modernize processes in line with evolving regulations and the external environment.
Required Qualifications
- Change leadership and innovative mindset: A genuine drive to challenge the status quo — bringing fresh thinking and bold proposals to how PMS is designed and delivered, while maintaining full regulatory compliance.
- Regulatory and scientific foundation: Solid knowledge of Japan's Pharmaceutical and Medical Device Act (PMD Act) and GPSP, or meaningful hands-on experience in a GxP-regulated environment; able to apply scientific judgment within a compliance-first framework.
- Post-marketing surveillance expertise: 5+ years of experience in post-marketing surveillance and investigations, with a strong track record of leading end-to-end PMS programs across multiple products or therapeutic areas.
- Database research experience: Proven experience planning and conducting post-marketing database studies, with the ability to translate research objectives into scientifically sound study designs.
- Medical and regulatory writing: Demonstrated ability to prepare high-quality regulatory documents, study protocols, analysis plans, and scientific reports to a standard that meets regulatory authority expectations.
- Strategic thinking and results orientation: Ability to balance regulatory requirements with forward-thinking scientific judgment — setting clear direction, making sound decisions under complexity, and driving outcomes with accountability.
- Stakeholder influence and communication: Exceptional coordination and communication skills across functions and seniority levels, with the confidence to engage regulatory authorities and align diverse internal and global stakeholders.
- Project leadership: Strong organizational and task management capabilities, with the ability to oversee multiple complex workstreams simultaneously while maintaining quality, compliance, and timelines.
- Languages: Business-level English communication skills (written and verbal); Japanese fluency required.
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