We are seeking a Global Clinical Publishing Associate to join our team in ensuring compliance with internal and external guidelines while compiling and enhancing electronic navigation for clinical and regulatory documents. In this role, you will play a crucial part in supporting the timely submission of documents to Health Authorities (HAs) and providing publishing consultancy to our clinical teams and other line functions.
About the Role:
Major Accountabilities:
- Collaborate with clinical teams to compile, integrate, and publish clinical documents using word processing, electronic publishing, and document management systems within the Novartis Development environment.
- Conduct technical quality control checks on published documents, ensuring electronic functionality and adherence to internal and external document standards.
- Maintain a basic understanding of current electronic publishing standards, regulatory guidelines, and legal requirements.
- Serve as the Program Publisher for various programs in clinical development under direct supervision.
Key Performance Indicators:
- Publish clinical documents in accordance with department standards and organization KPIs, considering complexity and size.
- Ensure published clinical documents meet internal and external quality standards for HA submissions, minimizing technical QC findings and avoiding rework.
- Deliverables meet individual document and overall project timelines.
Minimum Requirements:
- Experience with regulatory submission format and familiarity with submission publishing activities and CTD format criteria.
- Strong interpersonal, written, and oral communication skills.
- Proficiency in project management and time management to handle multiple projects concurrently.
- Knowledge of regulatory requirements and HA guidance, including FDA regulations, ICH, and EMA guidelines/directives.
- Working knowledge of regulatory affairs and ability to work independently with minimal supervision.
- Proficiency with computer programs/systems (MS Office, etc.) and ability to quickly learn new systems.
- Analytical and problem-solving skills, with the ability to coordinate and work effectively with cross-functional teams.
Work Experience:
- Cross-cultural experience.
- Functional breadth.
- Collaboration across boundaries.
- Operations management and execution.
- Project management.
Skills:
- Clinical study reports.
- Data analysis.
- Documentation management.
- Life sciences.
- Operational excellence.
- Regulatory compliance.
Languages:
- English.