Specialist (m/f) Regulatory Informatics and Submission Management

Wir suchen für unseren Kunden in Darmstadt möglichst ab sofort Unterstützung.

Beschreibung
In this position your key tasks and responsibilities comprise the following:
Responsibility for providing technical services and support to the unit for the publishing, production and archiving of regulatory documents across the product lifecycle
•Managing small technical and • business related projects
• Responsibility for the training on publishing tools and other DDM/GRA tools
• Ensuring the preparation and dispatch of submissions in a timely manner
• Managing all technical aspects of a submission and giving technical guidance Decisions on the acceptance of the technical quality of a dossier in close collaboration with the Dossier and Submission Manager
•Evaluating and deciding on parent dossier strategy and dossier structure for an assigned product portfolio in close collaboration with the Dossier and Submission Manager
•Compiling dossiers (using electronic submission tools, supporting hyperlinking and bookmarking of documents used in electronic submissions
• Publishing and producing dossiers, performing quality checks and dispatching dossiers Defining, implementing and tracking an optimal submission logistics strategy for the lifecycle activities of mature products
•Supporting the Dossier Task Force Lead in defining and implementing the submission management and publishing strategy for a new Marketing Authorization application
• Participating in the design and implementation of standards (e.g. CTD, eCTD)
• May acting as key contact for authoring functions in the area of document submission readiness Supporting the gathering and dissemination of information about electronic submission capabilities from internal and external sources
•Evaluating and proposing an implementation strategy for electronic submission capabilities in collaboration with the Dossier and Submission Manager