Manager, Expert Scientific Writer

We are seeking a Manager, Expert Scientific Writer to lead the authoring of clinical/regulatory documents in Japan. The role requires strong writing skills in Japanese and English, experience in authoring regulatory documents, and knowledge of global pharmaceutical drug development. The Manager will work closely with the global team and lead the finalizing of domestic regulatory dossiers of clinical part, manage timelines, and ensure quality of work. The role also requires excellent organizational, communication, facilitation, and interpersonal skills in a cross-functional team.

Requirements

• B.S. in medical/pharmaceutical/veterinary/life-science area or three years or more experience in either pharmaceutical R&D industry
• PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a minimum of 3 years (MS) to 5 years (BS) in preparing regulatory submission documents or have equivalent credentials and experience
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
• Good understanding of the tendency of each review department of PMDA regarding the contents of review reports and inquiries
• Demonstrated ability required for strong writing skills both in Japanese and in English
• Ability to analyze and interpret complex data from a broad range of scientific disciplines
• Excellent organizational communication, facilitation and interpersonal skills in a cross-functional team
• Demonstrated ability to manage timelines and keeping quality of work

Benefits

• Competitive salary
• Benefits package
• Opportunities for career growth and development
• Collaborative and supportive work environment