1. Responsible for developing, drafting, editing, formatting, reviewing, and finalizing scientific reports, laboratory methods, and publications for various scientific disciplines (Bioanalysis, In Vivo PK, Pharmacology Microbiology, etc.) using Microsoft Word, Excel, and PowerPoint.
2. The position will be creating reports for non-GLP Discovery studies.
3. Conduct literature searches, interpret scientific literature, and prepare analyses, interpret, and summarize data, and evaluate study data from tables and listings.
4. Participate in group initiatives in relation to document standards, continuing template development, cross-functional processes and other aspects of document management (in collaboration with publishing group).
5. Perform other duties as required.
- ● 生命科學學門 相關科系
- 新北市五股區|月薪 35,000~50,000元月薪 35,000~50,000元|經驗不拘|大學|千大企業展開收合
1. Technical documents writing including
-Risk management plan and report
-Software validation plan and report
-Performance summary report
2. FDA/CE certificate application including
-administrative and technical documents preparation
-solve various problems in whole process
-file dossiers with quality management requirement
3.Product registration including new and renewal
4.Ensure to obtain the regulatory certificates on time for supporting business requirements.
5.Establish good working relationship with officials and experts in authorities, good communication and negotiation with officials and reviewers to guarantee smooth registration