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
Company Overview
◆グローバルランキング5位以内
◆ヨーロッパヘッドクオーター
◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ
◆癌領域に最先端の技術
Job Description
Job Purpose
・ To write and manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications and documentation for other purposes.
・ To provide leadership as a medical writer within submission teams, and authoritative documentation-related consultancy to Medical Writing group and other line units.
・ To provide medical documents which are met with end-clients’ objective and needs. Clients include Health Authority, investigators, patients and internal clinical development project related members.
・ To control various internal regulatory/medical documents to have them met the aligned Target Product Profile (TPP) through the development coordinating with related divisions.
Major Accountabilities
・ Act as a member of clinical trial teams following protocol finalization and write/edit clinical study reports.
・ Write/edit summary documents for submissions, other clinical/regulatory documents as required and according to availability of resource.
・ Analyze and interpret data and other information in order to determine the best approach to composing the document.
・ Compose initial draft of a document by referring to all information compiled in preparation for composition.
・ Integrate into the initial draft the input, expertise, and opinions from members of the authoring team and internal/external experts and business partners.
・ Compose the final document by referring to reviewers’ input and other information compiled.
・ Provide advice, support, and composition for designing content that can be reused in other deliverables.
・ Edit document to ensure document quality in regard to correctness of structure, content, language, and/or style.
・ Act as submission coordinator to ensure provision of adequate medical writing resources for dossier preparation and co-ordinate production of summary documentation in collaboration with clinical team.
・ Provide authoritative documentation consultancy to other line units on regulatory submissions and other documentation-related issues.
・ Lead development of document templates and documentation-related processes both within Medical Writing group and more widely.
・ Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
・ 100% timely delivery of all training requirements including compliance.
Requirements
・ Languages: Excellent written /oral English and local language.
・ Experience / Professional
Requirement:
・ At least 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus knowledge of the medical writing processes.
・ Extensive experience with clinical/regulatory documentation and publication writing.
・ Solid computer technical skills (Word/Excel/Powerpoint) to prepare documents.
・ Excellent medical writing skills and editing skills.
・ Expert data interpretation and presentation skills.
・ Excellent understanding of biostatistics.
・ Submission expertise.
・ Expert knowledge of regulatory requirements and clinical development, such as ICH guideline.
・ Experience of process improvement and quality management.
・ Experience in managing external medical writers.
Về cuộc phỏng vấn
Địa chỉ liên lạc
Medical writing, oncology
RGF HR Agent
500 〜 900 ten thousand JPY