社名非公開/Clinical Research Scientist(炎症・免疫)の求人【バイオ転職ナビ】

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Clinical Research Scientist(炎症・免疫) 急募求人  /  社名非公開

ジョブNo.NJB1035919
職種 Clinical Research Scientist(炎症・免疫)
社名 社名非公開
業務内容 <Responsibilities>
1. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents,internal or external presentations, etc.
3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
4. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents,CRS etc.
5. Participate in Development Planning for assigned compounds.
6. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
7. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
8. Collaborates and supports operational activities as need be.
9. Assist in establishing project budgets
10. Assist and lead with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
11. Participate and present at investigator meetings
12. Assist in document template design and SOP writing
13. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required
14. Lead team meetings as required
15. Support J-submission
求める経験 An advanced degree in a relevant field (Ph.D., Pharm.D or equivalent advanced degree, with
experience in clinical research and development. 2-5 years clinical drug development
experience preferred.
<Key experience / knowledge>
・Masters degree or equivalent degree in life sciences or medically related field preferred
・Typically 7-10 years experience in life sciences or medically related field, including at least 6 years of relevant clinical development experience (e.g., in clinical research, study management, etc.) in Biopharmaceutical Industry
・Extensive medical/scientific and clinical research knowledge
・Advanced understanding of TA/indication
・Knowledge of global clinical trial design and drug dev process, and working knowledge of basic statistics,pharmacodynamics & pharmacokinetics
・Knowledge of Good Clinical Practice (GCP), and applicable international regulatory requirements and guidelines
・Thorough experience in all phases of clinical dev process.
・Experience in Clinical project planning including oversight of study deliverables, budgets, and timelines
・Experience writing and presenting clearly on scientific and clinical issues, preferably Clinical protocols and ClinicalStudy Reports and regulatory submissions
・Experience collaborating and leading cross-functional teams (team/matrix environment)
・Experience in operational aspects of clinical trials, e.g. as a CRA or a Study Manager
・Experience working on clinical studies conducted internationally preferred
・Manages conflicts/issues with external partners and customers
<Competencies / skills>
・Ability to use scientific and clinical knowledge to conceptualize study designs
・Advance problem solving skills; ability to recognize and resolve virtually all problems/issues that arise
・Ability to lead cross functional efforts and teams
・Proficient Clinical project management skills
・Excellent skills in oral and written communication
・Strong presentation skills
・Excellent interpersonal, organizational, supervisory skills
・Strong computer skills (e.g., Word, Excel, Access, ProjectManagement software, etc.)
・Works under minimum supervision
<PREREQUISITES>
An advanced degree in a relevant field (Ph.D., Pharm.D or equivalent advanced degree, with experience in clinical research and development. 2-5 years clinical drug development experience preferred.
語学力 英語力:中級
勤務地
東京都
年収 1200万円 - 1500万円
雇用形態 正社員(期間の定めなし)

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薬事(管理職)

<担当する仕事内容の詳細> ・承認申請書類、届出書類等の薬事監査 ・GVP、GQP自己点検 ・製造販売中止製品の承認整理、後発医薬品の薬価基準収載手続き及び削除 ・薬事規制の対象となる添付文書、製品のパッケージ、広告等の監査 ・薬事規制に係る情報等の収集・分析及び関係部署への情報提供 ・薬事に係る相談と助言等

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