About the Role
This role offers a hybrid working arrangement, requiring 3 days per week in our Dublin, Ireland office. Ad-hoc working hours are necessary to overlap with the US as required.
Key Responsibilities:
* Electronically prepare, publish, and validate clinical deliverables and global regulatory submissions for quality review and dispatch purposes.
* Produce high-quality, clinical deliverables, and global submission outputs within agreed timelines and in compliance with worldwide health authority requirements and internal guidelines.
* Partner with cross-functional stakeholders across various therapeutic areas and regions to ensure seamless execution of tasks.
* Support the implementation of new technology, tools, and processes, contribute to ongoing initiatives, and identify opportunities for continuous improvement.
* Assist with submission resource planning activities as needed.
Requirements:
* Bachelor's degree in life sciences or a relevant field.
* Fluency in English.
* Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical industry.
* Familiarity with electronic clinical document publishing standards/formats, e.g., eCTD, EU CTR.
* 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, with experience working in a complex, global organization.
* Highly motivated, organized, and detail-oriented team player.
* Analytical thinker with excellent problem-solving skills and adaptability.
Why Novartis?
We strive to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world. We achieve this through the dedication and expertise of our associates, who drive us towards our ambitions every day.