[Osaka or Tokyo] Medical Writer of Drug Development

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Job details

Company overview

Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.

As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
We have a culture where employees work healthy and enjoy challenges, and have been awarded “World's Best Company” multiple times by Forbes, an American economic magazine.

Responsibilities

• 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

Requirements

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)

Salary

8 - 14 million yen

Location

Tokyo