Position Title: CMC Technical Writer

Department: Quality Evaluation (QE) Team

Reports To: Head of QE Team (VP)

Position Summary: Technical writer of CMC documents on biopharmaceuticals for regulatory submission

1.     Technical writing in English: SOPs, procedures, study reports, characterization reports

2.     Technical writing in English: CTD Module 3 for CTA(IND) and MAA(BLA), Briefing book for regulatory meeting, responses to agency’s questions

Requirements:

Education: Scientific background in the area related to biology and/or biotechnology

Experience: Experience on CMC technical documentation on biopharmaceuticals

Preferred Skills: Understanding on protein drugs is preferable

Other Requirement: Able to relocate to Korea and work within the company

                         Person unable to speak Korean is preferable

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