MANDATORY

• Applicants must have permission to work in Japan
• Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑Foreign business ☑English language required

[Position]
Senior Manager, Medical Writing

• Department: Regulatory Affairs
• Reporting to: Director, RA

[Company Description]
Global Insurance Company

[Responsibilities]

• Draft and edit documents used to support regulatory activities, including clinical CTD submission documents, Health Authority briefing packages/responses, clinical study reports, clinical trial protocols, and investigator's brochures.
• Drive cross-functional team participation in the preparation of such documents, including calling/scheduling/facilitating meetings, developing and managing timelines, document review, and decisions.
• Provide peer review and editing support for other clinical/regulatory documents, as needed.
• Adhere to guidelines, SOPs, and practices and technical and industry standards during all aspects of work.
• Support developing and reviewing standard processes and templates.
• Work effectively in cross-functional working groups.

[Requirements]
Mandatory:

• At least 7 years relevant medical or scientific writing experience in the pharmaceutical industry.
• Familiarity with all phases of drug development processes (discovery to market), clinical trial protocol design, CTN submissions, investigator's brochures, plans required for the conduct of clinical trials, and clinical trial data collection and results reporting.
• Experience preparing investigator's brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses.
• Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• General understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, EndNote, document management systems.
• Ability to interpret and summarize tabular and graphical data presentations.
• Skills to read scientific documents in English and communicate with the global members.
• TOEIC above 700

Preferred skills and experience:

• Oncology experience preferred, but not required if the candidate has demonstrated experience in other indication[s].
• Experience authoring clinical components in regulatory filings (NDA)(highly preferred) .
• Experience authoring clinical trial protocols (Phase 1-3) is preferred.
• Experience of completing Medical Writing Training Seminar by Union of Japanese Scientists and Engineers (preferred)

[Location]
Tokyo

[Salary]
10 million JPY - 14 million JPY (Experiences and skills will be considered)

[Welfare]
Social insurance

[Holidays]
Full 2 holiday week system (Sat/Sun), National holidays, New year's holiday, Annual Leave

[Selection Process]
Application screening and several interviews are scheduled.

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.

Reference: JO-2305-481340
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Writing / Editing, Research