Responsibilities:
* Responsible for writing, editing medical and regulatory writing, covering clinical research design, or the submission to regulatory agencies or Ethics committees, including the clinical study reports, create summary or changes, study protocols, etc;
* Work with teams and conduct literature searches, and evaluate and analyze the presented data;
* Ensures deliverables are in accordance with regulations, standards, and guidelines;
* The regulatory documents that the Medical Writer prepares must meet ICH, GCPs guidelines, and the clinical writing style guide;
* Understand the levels of evidence required to achieve regulatory, clinical assessment goals;
* Coordinate the review, approval, internal quality control. Resolve document content issues and questions arising during the writing process;
* Proactively identify and implement of the process improvements.
Qualification:
* Master degree at least, graduated in clinical medicine, public health or related majors, and at least 5 yrs of experience in clinical research field;
* Minimum of 2 years of regulatory document project management experience in working with collaborative, cross-functional teams;
* Extensive knowledge of a standard literature wiring style guide;
* High-level content writing experience and experience with clinical development regulatory documents required, with working knowledge of statistical concepts and techniques;
* Excellent written and oral communication skills;
* Ability to communicate scientific or medical information in a clear and concise manner;
* Familiarity with the principles or guidelines of clinical research;
* Ability to interpret and present clinical data and other complex information;
* Collaborative, ability to influence and cross functionally to reach qualified deliverables.