Major Accountabilities:
- In collaboration with the clinical teams, compile, integrate, and publish clinical documents using word processing, electronic publishing, and document management systems in the Novartis Development environment.
- Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents.
- Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.
- Under direct supervision of the immediate manager, act as the Program Publisher for various programs in clinical development.
Key Performance Indicators:
- Publish clinical documents (considering complexity and size) in accordance with department standards and organization KPIs.
- Ensure published clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technical QC findings and avoiding rework once finalized.
- Timeliness of deliverables meets both individual document and overall project timelines.
Minimum Requirements:
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Effective interpersonal skills, strong written and oral communication and presentation skills.
- Project management and time management skills to manage multiple ongoing projects simultaneously.
- Familiarity with regulatory requirements and HA guidance, including FDA regulations, ICH, and EMA guidelines/directives.
- Working knowledge of regulatory affairs.
- Ability to work independently and with minimal supervision.
- Proficiency with computer programs/systems (MS Office, etc.) with demonstrated ability to learn new systems quickly.
- Analytical skills and problem-solving skills.
- Ability to coordinate and work effectively with cross-functional teams.
Work Experience:
- Cross-Cultural Experience.
- Functional Breadth.
- Collaborating across boundaries.
- Operations Management and Execution.
- Project Management.
Skills:
- Clinical Study Reports.
- Data Analysis.
- Documentation Management.
- Life Sciences.
- Operational Excellence.
- Regulatory Compliance.
Languages:
- English.
