Position
Associate Director - Global Safety
Location: Plainsboro, NJ
Job Category: Regulatory Affairs & Safety - Pharmacovigilance
About the Department
Our East Coast Global Development Hub, located in Lexington, MA and Plainsboro, NJ, merges biotech speed with large pharmaceutical company quality, resources, and stability. We support early research through late-stage clinical development. This community thrives on collaboration, innovation, and cutting-edge research across various therapeutic areas. We are committed to improving human health and delivering new medicines for patients. Are you ready to make a difference?
The Position
The Associate Director - Global Safety will develop and execute the safety strategy for assigned programs within the U.S. East Coast Development Hub. In this role, you will collaborate with cross-functional teams and take responsibility for assessing and communicating the safety profile of Novo Nordisk products during both pre-approval and post-approval phases.
Key Responsibilities
Establish and maintain product safety profiles for assigned molecules/products.
Develop and update the minimum mandatory safety text (MMST) for Informed Consent documents.
Own and manage safety sections for the evolving Company Core Data Sheet (CCDS) for development products.
Oversee safety surveillance of products throughout their lifecycle (pre-approval and post-approval phases).
Conduct ongoing surveillance of all accessible data within assigned product areas and take action to mitigate risks in case of safety signals or alerts.
Perform periodic literature surveillance for marketed and development products.
Provide input for Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other safety-related documents.
Respond to requests from Health Authorities (HAs) and internal Novo Nordisk affiliates and functions.
Conduct product safety training within the therapeutic area of responsibility.
Chair and operate safety committees throughout the lifecycle of products.
Act as safety representative in cross-functional project teams, including global project teams (GPT) and trial squads.
Provide safety input to clinical trial protocols, clinical trial reports, Investigator Brochures (IB), and planned publications.
Support Risk-Based Monitoring activities across the development project.
Physical Requirements
Approximately 10% overnight travel required.
Qualifications
MD with 1+ year, PhD with 6+ years, MS with 8+ years, or BS with 10+ years of relevant global safety surveillance and/or clinical/drug development experience.
Excellent verbal and written communication skills.
Strong organizational and problem-solving abilities, with the capacity to thrive in a fast-paced environment and maintain a positive attitude under pressure.
Diversity & Inclusion
Novo Nordisk is committed to creating an inclusive culture that celebrates diversity. We value the perspectives, backgrounds, and experiences of all our employees and encourage applicants from all backgrounds to apply.
How to Apply
Interested candidates can apply through the Novo Nordisk Careers website.
Related Opportunities
Senior Director - Safety Surveillance (Plainsboro, US)
Associate Director - Medical Review (Plainsboro, US or remote)
Associate Director - Regulatory Affairs - Advertising & Promotion (Plainsboro, US)
About Novo Nordisk
Novo Nordisk A/S
Novo Alle 1, 2880 Bagsværd, Denmark
Phone: +45-4444-8888
CVR-no. 24256790
At Novo Nordisk, we are dedicated to improving the lives of people living with chronic diseases such as diabetes, obesity, and rare blood and endocrine disorders. For more information, visit our product page.
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