The Global Medical Writing departmentis responsible for ensuring that work undertaken meets the requirements of government regulatory agencies locally and worldwide. This responsibility includes the preparation of a variety of clinical documents including clinical study reports for Phase I to IV clinical trials run by Covance globally, in collaboration with other Covance units as necessary. It is the responsibility of theSenior Medical Writerto prepare such documentation to the required standard in a timely fashion. He/she is expected to acquire a competency in the use of Documentum and associated tools.

Senior Medical Writer, JPN *Japanese Required*
Requisition ID 44410
Job Category Clinical Research
Locations Japan, Tokyo
Shift 1

Responsibilities
• To carry out all activities in accordance with Covance standard Operating Procedures and Good Clinical Practice (GCP)
• To have a detailed knowledge of the Regulatory Guidances for ICHE3 Clinical Study Reports and for the Clinical (Efficacy) Sections of the Common Technical Document (CTD)
• To prepare documentation for regulatory submissions (e.g. investigator brochures, protocols, and clinical study reports) in collaboration with Clinical Research, Medical and Statistical personnel (as appropriate) to client and /or Covance specifications
• To provide advice on both local and global Medical Writing issues to project team members (internal and external to Covance) and help to resolve problems
• To provide advice and support for Business Development personnel regarding Time and Cost estimates, as requested
• To assist Senior Management to assess functional operations and plan for new procedures
Education/Qualifications • Minimum of first degree in life sciences (or equivalent)
• Approximately 3-5 years experience in the preparation of clinical documentation

Preferred:
• Advanced degree or certification
Experience • Excellent written and verbal communication skills both in Japanese and English
• Ability to write fluent and grammatically correct English and Japanese with an understanding of Medical and Scientific terminology and procedures
• Ability to work to tight timelines while maintaining accuracy
• Familiarity with Quality Assurance and Quality Control
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.

Please apply here.