Global Clinical Publishing Associate (Regulatory Affairs)


Job Description

26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.

We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team.

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

• 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

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you'll bring to the role:
• BS in life sciences or a relevant discipline with min 3 years of professional work experience
• 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

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Global Drug Development
East Hanover, NJ
Research & Development
Full Time
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Global Clinical Publishing Associate (Regulatory Affairs)

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