글로벌cro MW (1년 이상)
페이지 정보
등록자 :
강대필상무
등록일 : 21-02-19 09:20
기본정보
글로벌cro MW (1년 이상) | |||
임상 | 사원~차장 | ||
무관 | 무관 | ||
서류전형 -> 1차면접 -> 2차면접 | |||
2021-02-19 | 채용시 |
상세정보
본문[담당업무]
- 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 [자격요건] - MW I, II: Minimum 1 years~ Sr. MW: Minimum 4 years regulatory writing experience in clinical research, in healthcare, pharmaceutical CRO industry and/or related industry - Minimum bachelor degree (major in nursing, pharmacy, or other science-related background) from a recognized institution, and/or equivalent combination of training and experience - 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 |