Expert Regulatory Submission Publisher, DRA Ops

Job description

Job Description

Coordinate or lead project activities for submission level publishing as assigned, in support of Health Authority (HA) filings across product portfolios for Submission Management & Publishing within Drug Regulatory Affairs Operations group (DRA Ops). Apply in-depth knowledge and experience as a Subject Matter Expert in submissions and related technical systems (Documentum, eCTDXpress, Insight Publisher, ISI Toolbox, Rosetta Phoenix) to support compiling / publishing processes, verification, dispatch and management for all investigational, marketing authorization, lifecycle management, post approval change management of Novartis drug dossiers in electronic Common Technical Document (eCTD), Non-eCTD electronic Submission (NeeS) and paper formats. Apply extensive experience in all submission types and varying dispatch activities to worldwide Health Authorities, including US Food & Drug Administration (FDA), EU European Medicines Agency (EMA), and local health authorities in other countries, for global submission publishing. Liaise with publishing teams in USA, Switzerland and India for global collaboration. Support preparation, quality review, and timely dispatch of drug dossiers by global publishing team, other staff. Work in close collaboration with Franchise Head of Global Submission Publishing and Global Submission manager as assigned for respective franchise / activity. Provide strategic and operational expertise support to teams to ensure timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities. Support implementation of Technical Format requirements and collaborate with Submission Standards and Strategy team members in DRA Ops group to develop company business guidance on publishing deliverables. Partner across functions with Clinical, Preclinical, Research and Technical coordinators for minor submissions, to negotiate submission component target date as needed to meet target submission date. Provide continuous improvements for submission technical process (i.e., update existing business processes, author new processes) and knowledge transfer within DRA Ops.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

Expert Regulatory Submission Publisher, DRA Ops sought by Novartis Pharmaceuticals Corporation for East Hanover, NJ location. Must have Master's degree in Computer Science or related life sciences field and minimum 3 years of industry experience as technical expert support for electronic publishing in drug development, including extensive experience in Documentum, eCTDXpress, InSight Publisher, ISI ToolBox, Rosetta Phoenix technical systems for regulatory submissions, dossier management and dispatch of global drug dossiers to global health authorities (FDA, EMA, other authorities worldwide), and related scientific, technical and regulatory requirements for HA submission global publishing. Requires experience in support for implementation of Technical Formats and development of business guidance for publishing deliverables, and continuous improvement for submission technical processes; collaborating globally with US & international publishing teams and cross-functional Clinical, Preclinical, Research, Technical partners; with proven ability to manage multiple projects in publishing for drug regulatory affairs operations. Respond to NPC, Attn: K. Oakley Req 206197BR, Bldg 110 Rm 244, 1 Health Plaza, East Hanover, NJ 07936-1080 or online www.novartis.com/careers. Novartis is an EOE.