About the Role
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.
