Global Submission Manager Novartis - Basel
Novartis Pharma AG is looking to hire a Global Regulatory Submission Publisher to be based in Basel, Switzerland. The Global Regulatory Submission Publisher:
Is responsible for the Global Submission Publishing of all global submissions and their dispatches to worldwide Health Authorities (FDA, EMA, LATAM, ROW).
Is accountable for all publishing, verification, dispatch and management of submission dossiers for all (investigational, marketing authorization, lifecycle management, post approval change management) NVS drug dossiers (e-CTD, NEES, Paper) under limited or no supervision.
Liaises with a team of Publishers located in EH, Switzerland and India.
Works in a global capacity with colleagues across these regions. Supports the rest of the global publishing team and other temporarily assigned staff in preparation, quality review, and timely dispatch of drug dossiers.
Works in close collaboration with the Franchise Head of Global Submission Publishing and Global Submission manager, assigned to respective franchise/activity with clear accountability for publishing process.
Provides strategic and operational expertise to teams for routine or maintenance submissions to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities (EMA, FDA, Swiss Medic, LATAM, ROW)
Is responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned maintenance of regulatory submissions for the assigned franchise.
Ensures adherance to internal standards, processes and Health Authority’s requirements.
Reports and updates Franchise Head for Submission Publishing on submission progress. Provides monthly report to FH-GSP and line management within DRA Operations. Identifies issues and solutions related to timing, quality and resources.
Partners with LF (Clinical, Preclinical, Research and Technical) Coordinators (or designee) to negotiate every submission component target date with the goal of achieving the target submission date.
Is responsible for the Global Submission Publishing of all global submissions and their dispatches to worldwide Health Authorities (FDA, EMA, LATAM, ROW).
Is accountable for all publishing, verification, dispatch and management of submission dossiers for all (investigational, marketing authorization, lifecycle management, post approval change management) NVS drug dossiers (e-CTD, NEES, Paper) under limited or no supervision.
Liaises with a team of Publishers located in EH, Switzerland and India.
Works in a global capacity with colleagues across these regions. Supports the rest of the global publishing team and other temporarily assigned staff in preparation, quality review, and timely dispatch of drug dossiers.
Works in close collaboration with the Franchise Head of Global Submission Publishing and Global Submission manager, assigned to respective franchise/activity with clear accountability for publishing process.
Provides strategic and operational expertise to teams for routine or maintenance submissions to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities (EMA, FDA, Swiss Medic, LATAM, ROW)
Is responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned maintenance of regulatory submissions for the assigned franchise.
Ensures adherance to internal standards, processes and Health Authority’s requirements.
Reports and updates Franchise Head for Submission Publishing on submission progress. Provides monthly report to FH-GSP and line management within DRA Operations. Identifies issues and solutions related to timing, quality and resources.
Partners with LF (Clinical, Preclinical, Research and Technical) Coordinators (or designee) to negotiate every submission component target date with the goal of achieving the target submission date.
Desired Skills & Experience
BS/MSc or comparable relevant experience and demonstrated capability2-4 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, dossier management and dispatch of global drug dossiers (US, EU, Asia, Latin America, etc).
Expert in HA submission publishing requirements globally
Excellent verbal and written communication skills as well as proven negotiation skills
Strong knowledge of regulatory business processes and related tools (document management, publishing, etc.) is desirable
Strong IT knowledge or experience using different IT tools preferred
Team management experience with cross functional responsibilities is a plus
Fluency in English as a business language. Additional language is an asset
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