The Global Clinical Publishing Associate will ensure compliance with internal and external guidelines while compiling and adding electronic navigation to clinical and regulatory documents. This role supports the timely submission of documents to Health Authorities (HAs) and provides publishing consultancy to clinical teams and other functions within the organization.
About the Role:
Key responsibilities include:
- Collaborating with clinical teams to compile, integrate, and publish clinical documents using word processing, electronic publishing, and document management systems within Novartis Development.
- Performing technical quality control (QC) of published documents, ensuring they adhere to both internal and external document standards, including electronic functionality.
- Maintaining up-to-date knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.
- Acting as the Program Publisher for various programs under direct supervision.
Key Performance Indicators:
- Ensuring the timely and accurate publishing of clinical documents according to department standards.
- Meeting internal and external quality standards for electronic and/or paper submissions to Health Authorities (HAs), minimizing publishing-related technical QC issues, and ensuring no rework after finalization.
- Delivering documents in line with project timelines and individual document deadlines.
Minimum Requirements:
- Experience with regulatory submission formats, familiarity with submission publishing activities, and CTD (Common Technical Document) format criteria.
- Strong interpersonal, communication, and presentation skills (both written and oral).
- Project management skills and the ability to manage multiple projects simultaneously.
- Familiarity with regulatory requirements and Health Authority guidance, including FDA regulations, ICH (International Council for Harmonisation), and EMA (European Medicines Agency) guidelines.
- Knowledge of regulatory affairs and the ability to work independently with minimal supervision.
- Proficiency in MS Office and other computer systems, with an ability to quickly learn new tools.
- Analytical and problem-solving skills.
- Ability to coordinate effectively with cross-functional teams.
Work Experience:
- Experience in cross-cultural environments and collaboration across organizational boundaries.
- Demonstrated functional breadth and expertise in operations management and execution.
- Project management experience.
Skills:
- Expertise in Clinical Study Reports (CSRs), data analysis, and documentation management.
- Knowledge of life sciences, operational excellence, and regulatory compliance.
Languages:
- English (fluent, both written and spoken).
AD
