job title: clinical publishing associate(novartis)

Key Responsibilities

• 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.

• 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

• 3-5 years submission publishing experience in Pharma or related industry.

• 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 guidances, 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.