北京招聘

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Job Description:
Accountable for Publishing, management of printing and binding, dispatch and archiving of China DRA Ops supported submission dossiers. Participates and supports China submission management process to ensure high quality electronic and paper submissions to local Health Authorities.
1. Accountable for Publishing, management of printing and binding, dispatch and archive of China DRA Ops supported submission dossier.
2. Works in close collaboration with local Submission manager, assigned to respective project with clear accountability for publishing process.
3. Provides operational expertise to minor maintenance submissions to ensure the timely, quality preparation and execution for submissions to China Health Authorities.
4. 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.
5. Reports and updates Submission Manager for Submission Publishing on submission progress. Identify issues and solutions relating to timing, quality and resources.
6. Participates in other department activities / initiatives as required.
7. Support Label artwork review, e.g. TVT comparison.
8. Support other assigned tasks.

Idea Background:
1. Bachelor with comparable relevant experience and demonstrated capability;
2. Good in English and Chinese (oral and written);
3. At least 1 year of working experience in pharmaceutical industry or formatting related field, with relevant experience in dossier management and formatting;
4. Strong knowledge of techniques for electronic compilation and publishing submissions. Familiar with state of the art publishing and document management software and the concepts required to produce regulatory submissions using these technologies;
5. Have good skills or understanding to use IT tools.