开发创新疗法是科学领域中最具挑战性、最重要和最有个人价值的领域之一。在我们追求将创新科学转化为患者价值的过程中,成为安斯泰来的一员是一个令人兴奋的时刻!我们是一家拥有独特的合作和以患者为中心的文化的公司。现对以下职位进行公开招聘,欢迎符合条件的候选人投递简历。

Location Shanghai

 

Responsibilities:

1Document development

• Drafts documents by integrating cross-functional input and ensures that the document communicates the information necessary to satisfy internal and external audience needs. Creating a needed document component or subcomponent (e.g., End-of-Text Table, citation list, appendix). 

2Coordinate the document review process and work with cross functional team

• Interacts with members of document working group/author team/document scientific lead in order to complete assigned responsibility. Coordinate the review process. 

3Document revision

Revises documents. Revision tasks include: 

• Ensuring data consistency and document integrity across the document by critically evaluating comments and incorporating them appropriately. 

• Addressing all comments in collaboration with responsible content authors and scientific document lead. 

• Facilitating issue resolution in collaboration with the document scientific lead. 

• Documenting course of action (incorporation or reason for non-incorporation) for comments/edits for reviewers. 

• Drafting an updated document.

4Editorial work and Quality check

• May perform editorial work if required. 

• May perform quality check or oversee the document quality of CRO.

5Others

• Based on the work arrangement.

6Documents scope

• Protocol, CSR, narratives, CSR appendices, briefing document, CTD dossier, regulatory responses, publication, manuscript, etc.

 

Qualifications 

1Education & knowledge

• Education: Bachelor’s degree or higher, pharmacology or biology preferred.

• Knowledge: ICH/Chinese GCP.

• Compliance and Pharmacovigilance.

• Pharmaceutical industry environment.

• Clinical development process.

2Skills

• Medical writing skill.

• Fluency in English.

• Excellent writing in English and Chinese.

• Be good at communication and cooperation.

• Excellent negotiation skill.

3Experience

• Training/experience of Medical Writer in clinical development in the pharmaceutical industry/CRO.

 

职位申请:

简历接收邮箱: [email protected] (邮件主题:应聘岗位-姓名-地区)