Risk Manager/ RBQM Partner (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Clinical Development

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Are you passionate about driving quality and ensuring patient safety in clinical trials? Do you thrive on identifying and mitigating risks while collaborating with global teams to enhance trial efficiency?

Join our dynamic team and lead the charge in revolutionizing risk management across clinical trials. Be the expert, facilitator, and collaborator we need to drive innovation and excellence!

Become part of a company dedicated to innovation and making a difference in patients' lives. Apply today and take your career to the next level!

The position
As a Risk Manager/ RBQM Partner, you will act as an expert, facilitator, and collaborator across all parties involved in study risk management activities. You will be involved early in the protocol development process through clinical study report submission to support risk identification, risk assessment and risk action planning and communication. You will collaborate with all relevant stakeholders and risk owners for coordinated and ongoing/periodic monitoring of risks for multiple studies. Additionally, you will act as a single point of contact for risk management for relevant stakeholders for your assigned programs and ensure timely communication and coordination of RBQM activities.

Key responsibilities:

• Initiate and facilitate program and study-level risk management.
• Provide RBQM expertise to trial teams to support efficient and applicable decision-making.
• Collaborate closely with assigned Central Monitors and Developers to ensure adequate central monitoring and risk detection.
• Act as a change champion and subject matter expert for RBQM.
• Facilitate knowledge sharing and lessons learned across risk management leads and stakeholders.

Qualifications

• MSc in Bioscience, Medical science, Data science, or a related field. Other relevant backgrounds will be considered.
• Strong understanding of drug development processes within the pharmaceutical industry.
• In-depth experience with Risk-Based Quality Management Strategy
• Minimum of 3-5 years of experience working in a pharmaceutical company or CRO (Contract Research Organization).
• Practise in Good Clinical Practice (GCP), ICH E6 Guidelines, and other applicable regulatory requirements.
• Analytical mindset, with the ability to critically evaluate and communicate.

You are someone who can quickly gain therapeutic expertise in new areas as needed. As a proactive problem-solver, you anticipate challenges and find effective solutions. As strategic thinker, you can lead and drive initiatives with a focus on results. With strong communication skills, you can clearly convey complex ideas to various stakeholders. You collaborate effectively across diverse teams, bringing out the best in others. Additionally, you inspire confidence and demonstrate initiative in all aspects of your work.

About the department
We are committed to driving the adoption of Risk-Based Quality Management (RBQM) across trials and globally. Recently, we embarked on implementing a central monitoring platform, which means we are building the business as we develop it.

To be the best versions of ourselves, we depend on each other and value a proactive approach to finding the best paths forward. Our team consists of 18 colleagues from diverse life science backgrounds, with some working virtually and others based in Denmark. We meet in person each year and maintain strong day-to-day collaboration, including fun and informal online competitions.

Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.

Contact
For further information, please contact Ida Holme at idhh@novonordisk.com

Deadline
6 April 2025

Please include a few sentences about why you are applying for this position in your CV. You do not need to attach a cover letter to your application.

At Novo Nordisk, we are committed to an inclusive recruitment process and equality of opportunity for all job applicants. To ensure a fair recruitment process, please refrain from adding a photo to your CV.

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.