东莞招聘

职位描述：
?Job Purpose
Accountable for Publishing, management of printing and binding, dispatch and archiving of China DRA Ops supported submission dossiers. Partici-pates and supports China submission management process to ensure high quality electronic and paper submissions to local Health Authorities.


Major Activities
Accountable for Publishing, management of printing and binding, dispatch and achive of China DRA Ops supported submission dossier.
Works in close collaboration with local Submission manager, assigned to respective project with clear accountability for publishing process.
Provides operational expertise to minor maintenance submissions to ensure the timely, quality preparation and execution for submissions to China Health Authorities.
Responsible for managing all aspects related to the preparation, compilation, publishing and format technical quality control of all assigned maintenance regulatory submissions. Ensure adherence to internal standards and processes, as well as Health Authority’s requirements.
Reports and updates Submission Manager for Submission Publishing on submission progress. Identify issues and solutions relating to timing, quality and resources.
Participates in other department activities / initiatives as required.
Support Label artwork review, e.g. TVT comparison.
Support other assigned tasks.




Ideal Background


Comprehensive knowledge in Microsoft Office is pre-requisite, and knowledge in commonly-used Formatting Tools is a plus.

Minimum 1-2 years working experiences in document formatting, preferable in translation service. Experience or basic knowledge in project coordination is preferable, but not necessary.

Basic knowledge in Biological /Medical/Pharmaceutical sciences is an advantage, but not necessary. 举报 分享

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