跨国药厂招聘注册助理

现在帮一家跨国药厂招聘entry level的注册助理，有兴趣的朋友快来应聘，工作地点在北京。英语流利是必需条件。
电话：021-51558906 邮箱：jackysun@21cnmanager.com
Responsibilities

Performs quality control of PDF documents with respect to technical compliance and updates documents to meet eCTD standards including technical format according to current ICH, FDA and EMEA as well as internal company guidance. This includes quality control and creation of bookmarks and hyperlinks as well as margins and legibility along with other advanced Adobe Acrobat editing functions.
Performs quality control on Word documents and updates Word documents to ensure that technical formatting requirements are met. Uses advanced Word features in lengthy and structurally complex documents.
Prepares Case Report Forms according to FDA guidance, introducing advanced navigation features.
Performs a technical review on regulatory relevant documents including the usage of various software tools and advises all disciplines of any corrections to be made regarding the format of these submission documents
Performs the compilation of Clinical Study Reports (CSR) including an internal technical review of the published result according to the current regulatory requirements
Uses technical computer know-how/experience to work independently and apply problem-solving skills to address issues with software functionality and/or publishing output. Tests hypothesis, proposes solutions and shares learning experiences with other Global Submissions staff. Accountable for thorough quality assurance validation and release of dossiers prior to submission.
The incumbent assists in the implementation and maintenance of electronic submission/document management standards, processes, and procedures which apply internationally and across disciplines.
Assists in the evaluation and validation of new software functionality or IT-systems used in the electronic submission process in order to keep up with evolving Health Authority guidelines/regulations as well as for process improvement and productivity/efficiency initiatives.
Qualifications

Education:

The incumbent is required to have a Bachelor’s Degree or equivalent
Personal characteristics

Very careful and patient
Good at logical thinking and problem solving
Courteous interaction with professional staff at all levels within BSP worldwide
Intermediate written and oral English communication skills are necessary