한국로슈 Clinical Operations Lead(IND&Clinical Trial Regulation)정규직 채용 1983년 05월 14일에 설립된 의약품 도매업업종의 의약품(항악성종양제,감염치료제,면역억제제,항고혈압제,골다공증치료제),의료용품 도소매사업을 하는 대기업, 1000대기업, 외국인 투자기업, 외부감사법인, 수출입 기업 입니다. |
|
모집부문 및 상세내용공통 자격요건 | Clinical OperationsPDG Korea 0명 지원자격 | ㆍAffiliate: Roche Pharma Korea Cluster: PDG Korea Work location: Seoul, South Korea Your key responsibilities Portfolio Delivery is the responsibility and accountability of all members of PDG and is necessary for the success of PDG (Roche). It encompasses how you actively partner and influence stakeholders, and foster collaborative relationships that enable us to drive impactful results. Through your commitment to streamlined processes and effective partnerships, you contribute to Roche's overall success and the advancement of patient care. Compliance: all PDG roles are expected to know their respective compliance requirements, including training, as well as execute all work in a compliant manner Office presence in line with local guidelines Financial Stewardship of our spending and resources
Key accountabilities (but are not limited to) Review and preparation of document packages for IND submission, including both protocol and CMC(IMPD summary translation) Overall IND submissions to MFDS (new protocol with new molecule, new protocol, protocol amendment, CMC amendment) Access internal, external communications related to clinical trial regulations. Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements Actively communicate with global/ government/ industry bodies to set strategy Provide appropriate country IND submission strategies, being agile to updated guidelines. Input into label review Build positive networking with relevant authorities/bodies to collaborate for further enhance clinical trial process, government policies/ laws, through innovative approaches
Who you are: You believe in the principles of Customer-Centricity, Human-Centricity, Growth Mindset, and Enterprise View. You thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational. You apply your organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operation’s programs, studies, and/or enabling projects. You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener. You have established in career with at least 4 years of relevant experience and have working knowledge of Drug Development and Clinical Operations or related areas of expertise. Minimum 1 years of experience in IND initial submission and approval will be preferred.
|
ㆍ기타 필수 사항
| |
|
| 근무조건ㆍ근무형태:정규직 | ㆍ근무일시: | ㆍ근무지역:(06615) 서울 서초구 서초대로 411 GT TOWER(서초동) |
| 전형절차
| 접수기간 및 방법ㆍ접수기간:2024년 7월 18일 (목) 12시 ~ 2024년 7월 26일 (금) 24시 | ㆍ접수방법:홈페이지 지원 | ㆍ이력서양식:자유양식 | ㆍ제출서류:Submission:
English and Korean resume and self-introduction in 1 MS Word file or PDF file.
Please include your current salary and expected salary information in resume.
국, 영문 이력서와 국, 영문 자기소개서를 1개의 MS Word 혹은 PDF 파일로 제출
이력서 상단에 현재 연봉과 희망 연봉을 반드시 표기하시기 바랍니다. 누락 시 이력서가 검토되지 않습니다.
(보훈)취업지원대상자 우대- |
| 유의사항ㆍ학력, 성별, 연령을 보지않는 블라인드 채용입니다. | ㆍ입사지원 서류에 허위사실이 발견될 경우, 채용확정 이후라도 채용이 취소될 수 있습니다. | ㆍ모집분야별로 마감일이 상이할 수 있으니 유의하시길 바랍니다. |
|
|