About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?
Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.
Reports to the Executive Director – Clinical Development & Research. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other Novo Nordisk Inc. (NNI) skill areas. External relationships include expert advisory board members, investigators, regulators, academic and pharma associations and other consultants.
Clinical Study ManagementProvide regional medical & scientific input on trial outlines, trial protocols and ICFProvide input on country and site feasibility, as well as Site Selection and Initiation trainings for the monitorsReview medical monitoring plan and conduct monitoring activities as per the planManage all required local protocol amendments/deviationsAssist in the recruitment of investigators for clinical studies and provide medical support to investigator meetingsProvide protocol training, disease specific training and titration trainingAssure timely initiation of studies, act as liaison with Regulatory, project teams, and investigators. Support recruitment & retention activitiesObtain expert medical community input
- Evidence Generation Planning:
- Provide regional medical & scientific input to regional evidence generation planning and project strategic documents, including NNI evidence Generation Plans and Product Development Plans
Medical and Scientific Support for Other Company ActivitiesStay abreast of guidelines, current trends and medical practice in the assigned therapeutic area, including reports and intelligence on key and critical new technologies or treatment advancesRepresent NN in investigators’ and expert advisory board meetings, external professional societies, pharma associations, seminars, and conventionsProvide medical and scientific input to HEOR studies, RWE studies and value dossiers for market accessProvide medical and scientific input to Marketing/Market Access departments as needed
- Regulatory Liaison
- Write and/or review clinical sections of clinical trial reports, statistical reports, investigator’s brochures, INDs, NDA and responses to Regulatory questions
- Provide medical and scientific input to advisory committee hearings when requested
- Provide medical and scientific input to labelling
- Assist in the interpretation of regulatory guidelines and directives to judge risk and causality
Other Essentials:Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boardsCollaborate with other skill areas in NACD, CDSE, CMR and NNI in general to ensure seamless collaboration across skill areas
- Project Management Liaison:
- Assist in developing clinical program timelines, budgets, and strategies
10-20% overnight travel required.
- MD or DO required; additionally, a PhD would be ideal, not required
- A minimum of 6 years relevant experience required; academic research or pharmaceutical development experience preferred
- Board certification or relevant therapeutic area experience required
- Prior clinical research or related experience (e.g., monitoring of clinical studies, knowledge of drug development phases, statistical research methodology experience)
- Leadership skills; project management skills; effective communication and presentation skills
- Strong collaborative mindset required
- Must maintain necessary credentials and remain in good standing within the medical community and medical ethics boards its except those already vested, provided
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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.