Lead the authoring of clinical/regulatory documents in Japan and support the performance goals for the clinical development and regulatory submission in Japan.
Requirements
- B.S. in medical / pharmaceutical / veterinarian / 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
- Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
- Strong writing skills in Japanese and 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 benefits, services and programs
- Balance and flexibility in the work environment
- Opportunities for growth and development