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Senior Scientist
3 months ago
About the Department
Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We're changing lives for a living. 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 U.S. East Coast Development Hub 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 Senior Global Safety Lead/Director/Senior Director – Safety Surveillance, U.S. East Coast Development Hub.
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, DMCs, and Academia.
Individual Contributor role with no direct reports.
Essential Functions
Support establishment of the product safety profile:Support development and updates to the minimum mandatory safety text (MMST) for use in the Informed ConsentAssist in the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments productsMaintain the labelling for marketed products and is member of the Product Labelling Committee (PLC) Review GroupSafety 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), takes initial actions to mitigate risks in case a safety signal or alert is detected or aggravated and documents the results of the safety surveillance for the periodConduct periodic literature surveillance for marketed products and for development products (if applicable)Provide input to 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 HasSupport responses to requests from HAs and internally from NN affiliates and HQ functionsConduct product training within therapeutic area of responsibilityMembership 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 forwardEstablish, operate and coordinate the safety committee throughout lifecycle of the actual productResponsible for all areas related to patient safety in clinical trialsActs as member of the trial safety group for dose escalation decisions (phase I trials)Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB), integrated safety summaries, abstracts and planned publicationsProvide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as requiredEstablish and ensure deliverables to/from Data Monitoring Committees (DMCs)May act as a safety representative in cross functional project teams as needed e.g. Global Project Team (GPT)Plan, execute and drive all activities related to safety and ensures coordination with other project deliverablesHandle process changes and deviations in Safety Surveillance in close cooperation with relevant colleaguesAct as Change ResponsibleDecide how to document the change, according to applicable SOPEnsure that all changes are considered in relation to impact on release of productsAct as Deviation ResponsibleHandle all deviations (Minor/Major) according to applicable SOPEnsure a clear description of the deviation, and that content is correct and fully documentedDetermine and justifies the delimitationEnsure timely approval including action plan, or timely request for extension of the deadline Physical Requirements Approximately 10% overnight travel required. QualificationsDoctorate degree with 4+ years of relevant experience or a Masters with 8+ years' or Bachelor degree with 10+ years of relevant experience in global safety surveillance and/or clinical/drug developmentExcellent verbal and written communication skillsStrong organizational and demonstrated problem-solving capabilities, andAbility 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 diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.