Job Title: Global Clinical Publishing Associate
Qualification: Bachelors in life sciences or a relevant field with minimum 3 years submission publishing experience in Pharma or related industry.
200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.
Your responsibilities include, but are not limited to:
- Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs), and provide publishing consultancy to the clinical teams and other line functions.
- 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,nd legal requirements.
- Under direct supervision of the immediate manager, acts as the Program Publisher for various programs in clinical development.
- 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.
- Publish clinical documents (taking into account complexity and size) in accordance with department standards and organization KPIs.
What you’ll bring to the role:
- Bachelors in life sciences or a relevant field with minimum 3 years submission publishing experience in Pharma or related industry
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- Proficiency with computer programs/systems (MS office, etc.) with proven ability to learn new systems quickly.
- Effective interpersonal skills, strong written and oral communication and presentation skills
- Project management and time management skills to handle multiple ongoing projects simultaneously
- Ability to coordinate and work effectively with cross-functional teams