Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Sr. Associate Submission Specialist

Your tasks and responsibilities

 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 and/or GSMP management. Works independently on tasks assigned in preparation and coordination of (electronic) submissions.  Ensures achievement of submission milestone dates for assigned publishing support activities. Raises issues that risk the submission timelines and escalates the issues to the GSL to proposes appropriate resolution. Diversity of submission types and complexity
 include all potential dossier types worldwide across all phases of a product lifecycle.  The individual is responsible for applying respective global regulatory guidance and regulations associated with the technical assembly and publication of submissions with oversight from a GSL. Incumbent is responsible for the overall quality of the dossiers which must comply with all internal Bayer best practices, meet global regulatory requirements, and facilitate the review.  Uses technical computer know-how/experience to work independently on tasks
 assigned and apply problem-solving skills to address issues with software functionality and/or publishing output.  He/She is 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.  Also assists with development and maintenance of operational guidelines and best practices in accordance with Health Authority Regulations and Global Bayer standard operating procedures (SOPs). Assists in the evaluation and validation of new software functionality or IT-systems used in the



 BS or equivalent (degreepreferred) in a life science or computer science and 2-3 yrs relevant experience or a MS in a life science or computer science with at least 1 year relevant employment experience.
 Relevant experience may be met via a combination of electronicdata/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.).

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Country: China
Location: BeiJing

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Last update: Jan 10, 2019   Copyright © Bayer AG