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About the Role
Contribute to the simultaneous development and submission of new drugs across the US, EU, and Japan through medical writing activities.
Responsibilities
- Prepare high-quality new drug applications, including domestic CTD clinical modules and responses to PMDA/MHLW inquiries.
- Prepare high-quality consultation materials for PMDA/MHLW and responses to their inquiries.
- Communicate and collaborate with internal departments, headquarters, domestic CROs, and other contractors via email and online/face-to-face meetings.
Requirements
- Experience in medical writing at a pharmaceutical company, CRO, or research institution.
- Hands-on experience writing domestic CTD clinical modules, referencing global CTDs and international literature, considering ICH guidelines and domestic regulations.
- Experience with NDA submissions in Registration Category 1, 2, 3, or 4 (New Ingredients, New Indications, Combination Drugs, or New Administration Routes).
- Proficiency in logical and precise Japanese writing.
- Reading and verbal communication skills in English.
- English-to-Japanese translation skills.
- Strong attention to detail based on expertise.
- Flexible and open mindset for cross-functional teamwork.
- Ability to provide expert medical writing perspectives to achieve business milestones.
- Ability to effectively utilize information and technologies, including generative AI.
Skills
- Medical writing
- Domestic CTD clinical module writing
- NDA submissions
- Japanese writing
- English communication
- English-to-Japanese translation
- Attention to detail
- Teamwork
- Generative AI utilization
Education Level
- Advanced degree in Medical, Pharmacy, or Life-science field (Bachelor’s degree or higher)
About the Company
- The Servier Group advances therapeutic progress for the benefit of patients.
- We are committed to therapeutic progress to serve patient needs.
- We value the diversity of our employees as a source of richness.
- We offer tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, and team spirit in a workplace focused on well-being.