1. ¸ðÁýºÎ¹®: Medical Writing Leader
´ã´ç ¾÷¹«:
- Conduct MW report review and Quality Control check regarding MW deliverable
- Prepare regulatory and clinical documents on behalf of Company in accordance with the ICH guidelines& international regulations
- Write and edit clinical documents and submission to the sponsor
Prepare protocols, clinical study reports, integrated summaries, all types of regulatory-agency submissions and medical writing as required
- Analysis and interpretation of clinical trial data in medical points of view
- Ensure quality of the documents & manage the document review process
- Ensure there is appropriate compliances with GCP, SOPs, guidelines and regulatory requirements
- Ensure compilation of appendices to trial reports
- Participate in project team meetings to provide input regarding deliverables, timelines, and processes
- Conduct literature searches,managing the literature database and prepare literature reviews for external and internal clients
- Performs other duties as requested by management
ÀÚ°Ý ¿ä°Ç:
- Minimum bachelor degree (major in nursing,pharmacy, or other science-related background) from a recognized institution,and/or equivalent combination of training and experience
- Minimum 5~8 years regulatory writing experience in clinical research, in healthcare, pharmaceutical CRO industry and/or related industry
- Qualified candidates must have experience writing protocols and protocol amendments, clinical study reports, investigator brochures, and all types of regulatory agency submissions
- Solid knowledge of the clinical development process, Good Clinical Practices,and the Medical Writing process
- Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature
- Proficiency using an electronic document management system including MS office applications
- Strong analytical ability to interpret clinical data
-Effective Written and verbal communication skills in both English and Korean
-Good organizational, leadership and interpersonal skills
-Advanced skills for issue-solving
2. ÀüÇü
- ¼·ù ¹× ¸éÁ¢ ÀüÇü (*ÇÕ°ÝÀÚ¿¡ ÇÑÇÏ¿© °³º° ¿¬¶ô)
3. Áö¿ø¹æ¹ý ¹× ¹®ÀÇ»çÇ×
- °æ·Â¼Ò°³ Áß½ÉÀÇ À̷¼ ¹× °£´ÜÇÑ ÀÚ±â¼Ò°³¼ ÷ºÎ (*¿µ¹® Çʼö)
- À̸ÞÀÏ Á¦Ãâ: ck_recruit@cmicgroup.com
4. º¹¸®ÈÄ»ý
- 4´ëº¸Çè °¡ÀÔ, ÅðÁ÷±Ý º°µµ, ź·Â±Ù¹«Á¦, ¹ýÀÎÈÞ´ëÆù Áö±Þ, Family week, ⸳±â³äÀÏ ÈÞ¹« µî
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003