Regulatory Operations Publishing Coordinator
4 days ago
About Us:
">Novartis Farmacéutica is a leading global healthcare company that is reimagining medicine to improve and extend people's lives.
">Our purpose is to bring innovative medicines to patients around the world, and we are committed to making a positive impact on society through our products and operations.
">We are seeking a talented Global Regulatory Publishing Associate to join our team and contribute to this mission.
">About the Job:
">This role offers the opportunity to work in a dynamic and collaborative environment, where you will be responsible for preparing, publishing, and delivering high-quality clinical documents and submissions to support our global regulatory strategy.
">You will work closely with cross-functional teams to ensure seamless delivery of clinical documents and submissions, and contribute to the implementation of new technology, tools, and processes.
">Key Responsibilities:
">- ">
- Preparation, publication, quality review, validation, dispatch, and archiving of electronic clinical documents and global regulatory submissions.">
- Production of high-quality clinical documents and submission outputs within agreed timelines and in compliance with worldwide health authority requirements.">
- Collaboration with cross-functional stakeholders to ensure seamless delivery of clinical documents and submissions.">
- Support for the implementation of new technology, tools, and processes, contributing to ongoing initiatives and training, and identifying continuous improvement opportunities.">
Requirements:
">- ">
- Bachelor's degree in life sciences or relevant discipline.">
- Fluency in English.">
- Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry.">
- Experience with electronic clinical document publishing standards/formats and global regulatory submission publishing standards/formats.">
- Working knowledge of publishing tools, global submission validation tools, document management systems, and MS Office tools.">
- Familiarity with global clinical and regulatory health authority requirements.">
- Strong interpersonal and project management skills, and experience working in a complex, global cross-functional organization.">
- Highly motivated, organized, and detail-oriented team player.">
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.">
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