Tóm tắt công việc
Nghề | Nghề yêu cầu chuyên môn (Tư vấn, Tài chính, Bất động sản, Dịch vụ chuyên môn)/Dịch vụ chuyên môn (y tế, phúc lợi xã hội, giáo dục, hướng dẫn viên) |
---|---|
Ngành | Y tế/ Các ngành y tế khác |
Hình thái tuyển dụng | Chưa phân loại |
Chức vụ | Cấp giám đốc trụ sở/điều hành kinh doanh |
Số lượng tuyển dụng | 1 người |
Ngày muốn vào làm | - |
Kỹ năng ngôn ngữ cần thiết | |
Ngôn ngữ có thể sử dụng | - |
Thời gian làm việc | Khác |
Ngày nghỉ / Phúc lợi y tế | |
Hỗ trợ xin visa | - |
Nhân viên người nước ngoài | - |
Chi tiết công việc
企業概要
眼科や循環器、オンコロジーに力を注ぐ、欧州系外資メーカー。
福利厚生が手厚く、女性管理職も多い企業です。
職務内容
• Independently representing CS in global project teams, if appointed as CPL leading global CS team and directing /coordinating the early clinical team (until D6) or contributing to clinical teams (after D6), respectively
• If appointed as CPL Independently creating, updating and implementing the CS development plan and presenting it on decision-making committees within the company
• Representing CS externally, e.g. in meetings with authorities, ethics committees and key opinion leader meetings.
• Providing medical as well as clinical pharmacological advice and expertise to design, plan, execution and evaluation of clinical pharmacological studies in close collaboration with the study teams
• Independently inspecting, evaluating and reporting new results within the context of development projects
• Drawing consequences from new results/critical processes, adapting the project plan by implementing appropriate measures to avert risks within the context of the drug development project
• Actively participating in specialist conferences, seminars/relevant educational events and taking into account the state of scientific knowledge and publications, local and international authority guidelines / requirements and in-house regulations (e.g. SOPs)
• As CPL, being responsible for coordinating of all CS activities related to preparation and submission of dossiers (NDA) and a state-of-the-art label
• Being independently responsible for content and timely provision of clinical pharmacological documents such as IB, IMPD, protocols, PSUR reports, study protocols, IND documents as well as publications.
• Independently providing medical and clinical pharmacology expertise in due diligences of potential in-licensing projects and in out-licensing activities
• Networking with in-house and external experts as well as key opinion leaders, academic institutions and contract research organizations
• Closely cooperate with other CS functions such as Pharmacokinetics, Global Biomarker, CS Operations and Experimental Medicine, as well as across functions with in-house and external project partners
• May provide medical expertise for specific studies (first in man, phase 1 studies with special pharmacodynamic methodology), if applicable at the location, in close collaboration with CS Operations group
Về cuộc phỏng vấn
Địa chỉ liên lạc
Senior PD Expert
RGF HR Agent
1100 〜 1400 ten thousand JPY