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Medical Writer / Non-clinical

Urgently Hiring
Job Category Medical Writer
Field Non-clinical
Language Direction -
Scope of Work
We are seeking nonclinical writers.
The responsibilities include preparing nonclinical documents such as Investigator’s Brochures, regulatory submission documents (CTD M2.4, M2.6, etc.), and responses to regulatory inquiries related to toxicology, pharmacology, and pharmacokinetics.
Experience in any one of the following areas is acceptable: toxicology, pharmacology, or pharmacokinetics?is also acceptable.
Requirements
Required:
・Knowledge of GLP, ICH, and other relevant guidelines, with experience preparing nonclinical documents at a pharmaceutical company or CRO
・TOEIC score of 700 or higher, or equivalent English proficiency
・Proficiency in Microsoft Office (Word, Excel)
・Use of Windows 11 or later, and Microsoft Office 2021 or later, or Microsoft 365 (Mac not acceptable)
・Strong research skills and excellent documentation skills

Preferred:
・Experience in preparing regulatory submissions for biopharmaceuticals or regenerative medicine products
・Ability to create templates and tables is a plus
Compensation
・Freelance, project-based contract work (remote)
・Paid per job or deliverable
Notes
* You may reapply for the same field after one year from the date of the notice of non-selection. We believe this period is necessary for further skill development.
* After passing the trial and registering with SunFlare, a work environment using a licensed version of Microsoft software is required (Microsoft Office 2021 or later, or Microsoft 365). Work cannot be assigned if unlicensed software is used.
* If you use a Mac, please ensure that you have a Windows environment set up and perform all work using a licensed version of Microsoft Office (Office 2021 or later, or Microsoft 365).
[Note] You are not required to purchase a licensed version of Microsoft software at the trial application stage.
How to Apply
Please click [Go to Application Form] below and submit the form after completing all the required fields. A confirmation email will be sent to you automatically after you send the completed form. After checking the email, please log in to the [Applicant Portal] to complete and submit your resume .
(If you have your own resume/CV or work history documents etc., please also upload them to the site as well.)

*Please note that you must log in to the [Applicant Portal] using the same email address you entered on the application form.
*If you do not receive the application confirmation email, please check your spam/junk folder or trash. All application steps can be completed by logging in to the [Applicant Portal] as well.

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