Novartis Global Clinical Publishing Associate

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.

Application Link