1. 招聘职位
  2. 工作地点
  3. 招聘人数
  4. 发布日期
  5. 应聘

岗位职责

1. Write, edit, review and manage the internal report development process to deliver technical reports for INDs, BLAs, MAAs, and associated regulatory submissions;

2. Collaborate closely R&D functional teams to ensure production of consistent, accurate, high-quality technical reports meeting regulatory requirements;

3. Perform literature searches as needed and summarize data for incorporation into documents;

4. Streamline, maintain and execute the end to end process for coordination of authoring, editing, reviewing, verifying and approving regulated technical reports;

5. Responsible for tracking all report deliverables for programs in scope;

6. Provide training to staff on the process of regulated technical reports as needed;

7. Write, revise and edit departmental SOPs as needed;

8. Performs other tasks as directed by the line manager.

任职要求

1. Advanced degree in life sciences preferred; 2 years+ of industry experience in regulatory writing;

2. Strong technical background in the field of antibody drug development is a plus;

3. Knowledge of FDA, EMA and NMPA regulations and ICH guidance;

4. Demonstrated writing skills with strong command of bilingual (English and Chinese) language and grammar;

5. Must possess excellent interpersonal, organizational, written and verbal communication skills along with ability to work collaboratively in a team environment;

6. Efficient, organized, and able to handle short timelines in a fast-paced, dynamic environment;

7. Proficient with document management software/systems, such as filing systems and ELN;

8. Prior supervisory experience preferred.

岗位职责

1. Working with the clinical team, the Medical Writer will be responsible for writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, and Patient Safety Narratives. Opportunities to write and contribute to Regulatory documents such as Clinical Summaries and Briefing Documents;

2. Reviewing documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR;

3. Provide appropriate input on others' documents, including review of key contributing documents, such as the SAP;

4. Represent medical Writing at cross-company and TA meetings;

5. Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly;

6. Manage processes and organize priorities;

7. Solve problems; Foster collaboration to resolve conflict;

8. Performs other tasks as directed by the line manager.

任职要求

1. Education of advanced degree in life science preferred;

2. Experience of minimum of 5+ years of industry experience to include a minimum of 3+ years of Medical Writing experience;

3. Demonstrated writing skills with strong command of bilingual (English and Chinese) language and grammar;

4. Have written CSPs, IBs, DSUR, ISEs and ISSs, Clinical Overviews and Summaries. Experience authoring RMP, Requests for PIP/PSP and PIP/PSP Waiver, clinical bioanalytical reports a plus;

5. Have the ability to work independently with team spirit;

6. Have a good working knowledge of PDF, and Project. Skilled in use of MS WORD. Have used 1 or more EDM systems.

岗位职责

1.根据公司总体战略发展需要,寻找与国内外生物制药企业,包括产品与技术引进、产品出口与技术转让、代理国外药企产品等方面的合作;

2.进行国外市场调研、业务拓展策划、可行性研究的工作,供决策部门作为决策依据;

3.执行对外合作项目的可行性论证,制定商业合作计划方案;

4.执行项目对外联系和沟通交流,安排、协调、陪同外国专家到现场开展工作,组织、编写项目技术资料及翻译(中英文互译); 

5.组织、召开项目会议并撰写会议记要;

6.完成领导交办的其他工作。

任职要求

1.具有很强的学习和综合分析能力,善于及时扑捉市场信息,及时跟进生物医药行业发展态势并形成报告;

2.具有良好的组织、协调和沟通能力及执行力,能确保项目按预定的时间节点完成可交付成果;

3.可用英文口语交流、具有很强的英文阅读和写作能力;

4.性格开朗,积极主动,有亲和力,具有很强的独立工作能力及很强的团队工作意识和能力;

5.沟通和协调解决项目相关产品开发临床研究中的相关问题,具有良好的工作协调和沟通能力;

6.具有生物医药行业研发、或商务拓展、或国外产品注册经验、跨部门/跨企业项目管理经验优先;

7.硕士或者以上学历包括医学、生物化学和生物技术等专业,国外留学经历优先,具有生物医药类药企经验者优先。

岗位职责

1.组织团队撰写、审核、发布、培训临床研究标准操作规程(SOPs)并保证其有效执行;不断完善工作流程和SOP
2.建立与质量相关的内部管理体系和制度;
3.建立部门人员培训体系和培训档案;
4.审计临床供应商,保证符合项目质量需求;对临床部外包试验的质量进行监督和管理;
5.制定项目稽查计划并管理稽查团队有效执行稽查计划,及时发现临床试验中存在的质量问题并监督运营团队进行整改;
6.组织和应对药政官方核查和其它单位对我方的审计。

任职要求

1.相关专业本科及以上学历;
2.8年以上临床试验相关岗位工作经验,其中4年以上临床QA工作经验;
3.熟悉GCP法规要求、熟悉药监管方核查工作流程和要点;具有成功应对核查的经验;
4.沟通能力强,能有效与外部、内部沟通,发现和解决质量问题;执行力强,能保证SOP和其它质量管理制度有效执行;
5.具有良好的英语沟通能力。

岗位职责

1.负责临床试验的运营组织协调,带领CRA团队、管理CRO和其它供应商、协调公司内部其它资源完成临床试验的全过程,保证预定的项目进度目标,质量目标得以实现;
2.制定合理的风险控制计划、规避试验过程中可能产生的风险;
3.保证项目团队严格遵循GCP法规和部门SOP,保证试验质量;
4.指导临床研究助理(CTA)管理项目预算、合同和支付进度;
5.管理和协调供应商,监督供应商的工作进度和质量,把控预算;
6.对项目CRA团队进行项目相关培训和具体指导;
7.配合公司的QA工作,及时整改存在的问题。

任职要求

1.相关专业本科及以上学历;
2.6年以上临床运营相关岗位经验;3年以上临床项目管理经验;有管理国际多中心临床研究的经验;
3.具有良好的抗压能力和执行力;良好的应变、沟通和协调能力;
4.性格外向,为人诚信、细致、严谨,有较强的责任感;适应出差;
5.有良好的英文听说读写能力,能够与外资供应商,国外中心研究者顺畅沟通,流畅阅读和起草项目相关的英文资料和文件。

应聘职位
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