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.).