Major accountabilities:

• In collaboration with the clinical teams, compile, integrate and publish clinical documents with 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, acts as the Program Publisher for various programs in clinical development.

Key performance indicators:

• Publish clinical documents (taking into account 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 no rework once finalized.
  • Timeliness of deliverables meet 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.
• Familiar with regulatory requirements and HA guidance, including FDA regulations, ICH and EMA guidelines/directives.
• Working knowledge of regulatory affairs.
• Works 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.
• Lifesciences.
• Operational Excellence.
• Regulatory Compliance.

Languages :

• English.