Featured Job
Medical Writer / CMC Regulatory Affairs
Urgently Hiring
Experienced Candidates Only
| Job Category | Medical Writer |
|---|---|
| Field | CMC Regulatory Affairs |
| Language Direction | - |
| Scope of Work |
We are seeking freelance CMC regulatory writers.
Responsibilities include preparing CMC-related documents, including CTD Modules 2.3 and 3 for marketing authorization applications, and responses to regulatory inquiries. |
| Requirements |
Required:
・Knowledge of GMP, ICH, and other relevant guidelines, with experience in CMC regulatory activities and preparing CTD Module 2.3 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 abilities Preferred: ・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. |