Job
Medical Writing JOB
About Medical Writing
Our medical writers are involved in the preparation of various application dossierss for submission to the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) for the approval for new drugs, medical devices, therapies, etc., and checking (quality control) of the contents of documents. Our medical writers also translate English documents into Japanese and prepare documents in English.
- Medical Writers are involved in creating applications for new drugs approval to deliver the fruit of latest medical technologies to patients.
- Since Medical Writers have numerous opportunities to come into contact with medical documents and the latest clinical trial results, they can acquire a high degree of expertise.
Specialty of CMIC
With our big team housing more than 70 Medical Writers, CMIC provides a wide range of medical writing services.
Since CMIC is involved with creating marketing approval applications for approximately 10% of all new drugs approved in Japan, our Medical Writers can work on numerous marketing approval applications leading to the launch of for the latest drugs.
Since we have a full program of training courses and many of our senior writers formerly worked in major pharmaceutical companies, even new hires who join without any experience can receive thorough guidance within CMIC.
Scope of Work Scope of Work
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- Preparation/Assistance inthe preparation of Common Technical Documents (CTD) for marketing approval application
- Preparation/Assistance in the preparation of Clinical Study Reports (CSR)
- Assistance in the preparation of Investigator Brochures (IB)
- Assistance in the preparation of protocols and related materials
- QC of various documents
- In addition to routinely translating English documents into Japanese, Medical Writers also prepare documents in English.
- Medical Writers are required to have knowledge on the latest medical and pharmaceutical affairs and ministerial ordinances (GCP, GPSP, etc.).
Skill Required Knowledge and Skills
- Document preparation and translation skills
- Medical and pharmaceutical knowledge
- Information research ability
- Communication skills
- English ability
Skill Knowledge and Skills gained on the job
- Professional knowledge in diseases, statistics, pharmaceutical affairs, legislation, etc.
- Ability to prepare various application documents
Career Paths Career Path Examples
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Mr.A
- Medical Writing (3 years)
- Manager in charge of preparing Clinical Study Reports (CSR) at Medical Writing Department
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Ms.B
- Medical Writing (5 years)
- Project Leader for preparing Common Technical Documents (CTD) at Medical Writing Department
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Mr.C
- Medical Writing (7 years)
- Medical Writing Group Leader
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Ms.D
- Medical Writing (with 10 years of experience in one's previous position)
- Project Leader for preparing CTD, and provide guidance and training of personnel as a Senior Medical Writer at Medical Writing Department
Data Data
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Academic background
Science
0
%Humanities
0
% -
New graduate to Mid-career Ratio
New graduates
0
%Mid-career
0
% -
Gender ratio
Men
0
%Women
0
% -
Age composition
20s
0
%30s
0
%40s
0
%50s
0
%over 60s
0
%
As of March 31, 2024