[ 招聘] 德国拜耳医药保健-全球注册事务部-注册专员

宋剑梅(UK)

Position Title : Senior Associate Submission Specialist

Brief info.: 拜耳全球注册事务部招聘注册类专员。要求医药，生物相关专业的硕士应届生。英文流利。有1-3年的注册相关工作经验的优先，海归优先。

简历请投递至：airry.s@hotmail.com

Task:

The Incumbent executes all operational activities associated with compilation, publishing and distribution of submission components and/or dossiers for new and lifecycle management projects submitted to local and/or global Health Authorities under the direct supervision of a Global Submissions Leader or GSM&A management.  As part of the submission compilation process, carries out the technical review / technical improvement and verification of the eCTD compliance of dossier-relevant R&D documents/reports consistent with appropriate standards.  This is achieved by enhancing the technical quality of submission relevant documents/reports and/or collaborating with authors.  The individual is trained on relevant Health Authority requirements regarding (electronic) submissions and processes. Responsible for applying all global regulatory guidance and regulations associated with the technical assembly and publication of submissions (paper, electronic and/or non ICH formats) with oversight from a GSL and/or GSM&A management.  Ensures achievement of submission milestone dates for assigned publishing support activities.  Identifies and documents issues that risk the submission timelines and escalates the issues to the GSL and/or GSM&A management to recommend appropriate resolution.

 

Requirements:

BS or equivalent (degree preferred) in a life science or computer science and 3-4 yrs relevant experience or a MS in a life science or computer science with 1-2 yrs relevant employment experience.

Relevant experience may be met via a combination of electronic data/document management, project management, computer systems or publishing software support, electronic document publishing and/or regulatory affairs.

Knowledge of drug development process and relevant SOPs is required along with an understanding of federal regulations, international standards (e.g. ICH), and regulatory guidances as they pertain to the development and filing of e-submissons. The ability to interpret implications of these regulations, apply them to daily operations and to respond appropriately to questions from peers and cross functional professional staff is imperative.

Must have an excellent working knowledge of word processing, document management, and desktop publishing software packages, including hands-on knowledge of various document types, authoring tools and file formats (such as MS office templates, PDF files, SAS program/transport files, XML program code, etc.). Additionally, previous experience with a document management or electronic publishing tools is needed (such as PDF Fusion, EZsubs, Core Dossier, ISI Toolbox, Docubridge etc.). Must have an excellent working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.).

Strong communication and interpersonal skills are needed to interact with global document authors and their support staff across international Bayer sites and across different functional departments. Multi-cultural sensitivity gained from some direct international experience is highly recommended

Exposure to the project management function, tools and techniques as they apply to Regulatory submission projects is highly desirable. Self-motivation, a sense of urgency, attention to detail, sound judgement, and good follow-through are also essential.