Manager, Expert Scientific Writer

Lead the authoring of clinical/regulatory documents in Japan. The scope includes clinical study reports, regulatory submission documents, briefing documents for PMDA consultation, regulatory response documents, and orphan drug designation.

Requirements

• B.S. in medical/pharmaceutical/veterinarian/life-science area or three years or more experience in either pharmaceutical R&D industry is mandatory.
• 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, preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA.

Benefits

• Competitive benefits
• Services
• Programs that provide employees with resources to pursue their goals, both at work and in their personal lives.