[Osaka or Tokyo] Medical Writer of Drug Development

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募集要項

会社概要

グローバルでのCRO市場において、トップレベルに位置付けられる医薬品開発業務受託機関の日本法人です。

業務内容

• PREPARATION OF CLINICAL
• TRIAL PROTOCOL- PREPARATION OF CLINICAL TRIAL SUMMARY REPORT
• PREPARATION OF DRUG APPROVAL APPLICATION MATERIALS (CTD: COMMON TECHNICAL DOCUMENT) (CLINICAL PART ONLY)
• PREPARATION OF INVESTIGATIONAL DRUG SUMMARY
• REVIEW OF ABOVE-MENTIONED DOCUMENTS
• CORRESPONDENCE BY AUTHORITIES (CLINICAL PART DOCUMENT CREATION, REVIEW, CONSULTING, ETC.)
• GENERAL CONSULTING FOR DOCUMENT CREATION THAT MEETS REGULATORY REQUIREMENTS
• CONTRIBUTING AS A LEADING ROLE IN THE ABOVE
• APPROPRIATE GUIDANCE TO INEXPERIENCED MEMBERS AND CONTRIBUTION TO MEMBER GROWTH

応募条件

EDUCATION & SKILL:

• UNIVERSITY GRADUATE OR ABOVE (UNDERGRADUATE DEPARTMENTS SUCH AS MEDICINE, VETERINARY MEDICINE, AGRICULTURE, LIFE SCIENCE), OR EQUIVALENT DEGREE
• ENGLISH: CONVERSATION
• JAPANESE: NATIVE

EXPERIENCE:

• PHARMACEUTICAL COMPANY, OR MORE THAN 3 YEARS OF EXPERIENCE IN MEDICAL WRITING WORK AT CRO
• EXPERIENCE AS A MEDICAL WRITER IN PREPARING MATERIALS SUBMITTED BY MAJOR AUTHORITIES
• INCLUDING THE PROCESS FROM PROTOCOL DESIGN TO APPLICATION FOR APPROVAL AND TECHNICAL ISSUES SUFFICIENT KNOWLEDGE OF CLINICAL DEVELOPMENT
• KNOWLEDGE OF REGULATORY REQUIREMENTS, ICH GUIDELINES, AND REGULATORY PROCESSES RELATED TO WRITING (INCLUDING CTD)
• ENGLISH SKILLS (TOEIC: 730 POINTS)

給与

800 - 1400 万円

勤務地

その他