BRS Consultant
Patrick Chang
Pharma
Job number: Job-00210485
Posted: 2024-01-30
[Osaka or Tokyo] Medical Writer of Drug Development
Great Company Culture
8 - 14 million yen
Other
Pharmaceutical
Research & Development
Job details
- Company overview
- In the global CRO market, it is a Japanese subsidiary of a top-level drug development contract entrusted organization.
- 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
- Other