Scientist - Global Safety

About the Department

The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference? 

 

The Position

This role would support development of safety strategy, major safety deliverables for assigned programs within the Boston Global Development portfolio in close collaboration with key stakeholders from Global Safety Surveillance and other cross functional teams. This role would assist in the ongoing assessment of safety profile of assigned molecules/products and communication of safety information to internal and external stakeholders. Motivated, collaborative, and science-driven global safety professional who wants to work with innovative investigational medicines.

 

Relationships

This position will report to Director/Senior Director – Safety Surveillance.

Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, and other affiliates. External stakeholders include Healthcare professionals, HAs, ECs, and DMCs.

Individual Contributor role with no direct reports.

 

Essential Functions

• Support establishment of the product safety profile:
  • Support development and update to the minimum mandatory safety text (MMST) for use in the Informed Consent
  • Assist in the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products
• Safety surveillance of Novo Nordisk products during pre-approval and post-approval phases:
  • Support ongoing and systematic surveillance of all accessible data within allocated product area(s), seek initial action to mitigate risks in case a safety signal or alert is detected or aggravated and documents the results of the safety surveillance for the period
  • Conduct periodic literature surveillance for marketed products and for development products (if applicable)
  • Assist in the preparation of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required by HAs
  • Support response to requests from HAs and internally from NN affiliates and HQ functions

• Membership of the NN cross-functional safety committees:
  • Participate as a member of the first safety committee chaired by non-clinical, where Safety Surveillance will resume chairmanship going forward
  • Coordinate the safety committee throughout lifecycle of the actual product
• Assists in patient safety in clinical trials:
  • Assist in the preparation of clinical trial related documentation and interaction with internal and external stakeholders as applicable

 

Physical Requirements

Approximately 10% overnight travel required.

 

Qualifications

• MD or PhD or equivalent degree with 2+ years of relevant experience or a life sciences/pharmacy nursing degree with 6+ years’ experience in global safety surveillance and/or clinical/drug development
• Excellent verbal and written communication skills
• Ability to thrive in a busy environment and maintain a positive attitude under pressure

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the