Medical Writing
What is Medical Writing?
Medical writing is to prepare various key documents from each stage of drug development with the goal of providing regulatory submission ready documents. For example, study synopsis at clinical study planning, protocol and informed consent form during clinical study conduct, clinical study reports after clinical study completion, and CTD or STED for regulatory submission. Medical writing also includes preparation of documents for PMDA consultation meetings at each clinical study phase and responses to inquiries from the PMDA.
Furthermore, documents for post-marketing surveillance reexamination, protocols for investigator-sponsored clinical studies, and medical research paper are also within the field of medical writing. Medical writing is required to be complied with relevant regulations and guidelines as well as being written scientifically correct and clear.
Features of Medical Writing offered by Medical Grown
We provide various documents in different fields. Medical Grown comprises a number of highly qualified writers with strong and diverse scientific backgrounds so that we can assign a writer who specializes in the required type of documents or scientific fields. This will ensure to provide fit-for-purpose documents.
Writing by experienced writers
Medical Grown comprises a number of writers with extensive writing experience more than 10 years, which made us possible to provide high-quality documents and will bring comfort to our clients.
Clients can let us prepare the entire content of each document on behalf of the client. In this case, the client does not need to give detailed instructions. Our experienced writer can make suggestions on documents being prepared by clients as consultation.
Job Description
① A person who has a minimum of a university degree in a science-related field, or an equivalent educational background.
② A person who has abundant work experience in writing at pharmaceutical companies, universities, research institutes, CROs, etc.
③ A person who has skills in scientific logic construction.
④ A person who has skills in writing easy-to-understand Japanese.
⑤ A person who can communicate smoothly with clients or our colleagues.
⑥ A person who can understand outline of the latest pharmaceutical regulations and relevant laws and regulations related to document preparation.
⑦ Ideally a person who has more than 10 years of experience in regulatory affairs and/or clinical development, M.D. or Ph.D., experience in writing contributed papers, and extensive knowledge and experience in the respective area of expertise.
Documents and Areas mainly contracted
Medical affairs
– Medical/Pharmaceutical Articles
– Conference Presentation
– Protocols and other documents for Clinical Research
*Services of biostatistics and native check are to be outsourced.
Pharmacovigilance/Post-Marketing Surveillance
– Periodic Safety Reports
– Reports of Use-Result Survey
– Reports of Reexamination
– Response to Inquiries
Medical Information/Marketing
– Product Brochures
(including materials for explanation to patients and explanation of therapeutic areas)
– Product Information Overviews
Clinical Study
– Investigator’s Brochures
– Protocols
Clinical Study Reports
– Common Technical Documents
– Materials for PMDA Consultations
Non-Clinical
– Medical/Pharmaceutical Articles
Available language
– Japanese/English
Cardiovascular Diseases
Gastrointestinal Diseases
Renal Diseases
Urinary system diseases
Cerebral Nervous System Diseases
Oncology
Regenerative Medicine
Medical devices
（endovascular treatment, surgery, orthopedics, etc.）
Basic fields
（Pharmacology,
Clinical Pharmacology, Behavioral Pharmacology, Experimental Animal Science, Toxicology, etc.）
*We are also available to write articles on information related to the medical field and prepare materials related to Digital Therapeutics (DTx).
Work Flow
Client
Order
Document preparation
Based on the client’s request, our experienced writers will prepare the document.
(We can also provide consultation on the drafting of a thesis outline, CTD drafting policy, etc.)
QC Check
Documents prepared by the writer are QC-checked by experienced personnel.
(We also accept requests for QC checks only.)
Delivery
Client
