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Medical Writer for Korean Life Sciences Project

remote,Seoul, South Korea
Writing

Description

We are currently seeking two skilled Medical Writers to join our Life Sciences Service Line for a high-profile project involving major clients within the pharmaceutical and Clinical Research Organization (CRO) sectors. This project requires the adaptation of life sciences documentation to meet the specific requirements of the Korean Ministry of Food and Drug Safety (MFDS). The ideal candidate will have significant experience in medical writing, specifically in adapting documents for MFDS submissions in Korea.

We are currently seeking two skilled Medical Writers to join our Life Sciences Service Line for a high-profile project involving major clients within the pharmaceutical and Clinical Research Organization (CRO) sectors. This project requires the adaptation of life sciences documentation to meet the specific requirements of the Korean Ministry of Food and Drug Safety (MFDS). The ideal candidate will have significant experience in medical writing, specifically in adapting documents for MFDS submissions in Korea.

Requirements:

  • Proven experience in medical writing, particularly in preparing documents for MFDS submissions in Korea.
  • Strong understanding of the pharmaceutical and life sciences industries.
  • Proficiency in English and Korean, with excellent writing skills in both languages.
  • Experience with XTM or similar CAT tools is preferable.
  • Ability to work efficiently under tight deadlines and manage weekly content volumes exceeding 5,000 words.
  • Excellent communication and collaboration skills.

  • Responsibilities:

  • Adapt life sciences documentation to conform to the requirements and format prescribed by the MFDS for submissions in Korea.
  • Work involves adapting the structure and text of documents and possibly creating summaries in Korean.
  • Ensure that all written materials are clear, concise, and scientifically accurate.
  • Collaborate closely with our project management team and clients to ensure adherence to project specifications and timelines.
  • May include translation and copy-editing tasks in addition to medical writing.

  • Key Details:

  • Task Type: Medical Writing & Adaptation
  • Content Specialties: Investigator-facing, Patient-facing, Pharmacy
  • Document types:
  • Preparation and consultation for IMPD and IND submissions in MFDS format, including amendments and queries, along with regulatory document translation and dossier creation
  • Source Language: English (en-US)
  • Target Language: Korean (ko-KR)
  • Expected Capacity: Weekly
  • Expected Volume: 5,000+ words per locale, per week
  • Rate: Flexible; hourly rate for medical writing tasks
  • Client Applications - CAT Tools: XTM (license provided)

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