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Clinical Outcome Assessment Specialist

4 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Would you like to be a part of the ambitious journey towards ensuring that patients' experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation? Are you ready to shape the future of clinical trials through clinical outcomes assessment (COA)? Do you thrive in cross-functional collaborations in a global environment?

Then, this is your chance as we are looking for a Clinical Outcome Assessment Specialist in Medical & Science, Patient Focused Drug Development (PFDD).

Our commitment to innovation extends to how we work. We offer flexible work arrangements, including the option to work fully remotely or onsite at our office in Søborg, Denmark, where our team is based.

The position

Patients' perspectives and experiences are important focus areas for Novo Nordisk when developing better treatments for people living with serious chronic disease.

We are looking for a person with skills, interest, and experience in developing and using COAs in clinical drug development, primarily to generate evidence to inform regulatory benefit-risk assessments and support labelling claims but also to inform payers' decision-making and scientific communication with health care professionals.

As Clinical Outcome Assessment Specialist:

  • You will have a pivotal role in developing COA strategies, COA-related interactions with health authorities, and will be responsible for the selection, modification, development, validation, and implementation of fit-for-purpose COAs in clinical trials.
  • You will be involved in other COA-related scientific activities, such as in-trial interviews.
  • Your engagement will encompass the entire drug development life cycle across Novo Nordisk's portfolio, from early planning and execution to the development of COA dossiers and other regulatory briefing books, as well as supporting the communication of COA outcomes through publications.
  • You will collaborate closely with stakeholders from Medical & Science, Market access, Regulatory Affairs, Clinical Operations, Outsourcing, Medical Affairs, and Marketing, as well as various external vendors and advisors.
Qualifications

To succeed in the role, we expect you to have:

  • Master's degree or above in a relevant field such as health economics, pharmacy, public health, psychology, medicine or epidemiology.
  • 4+ years' experience in COA development and validation methods with knowledge of collection, analysis, and reporting of qualitative and quantitative data.
  • Knowledge of clinical drug development and relevant regulatory guidelines (preferred).
  • The ability to manage multiple priorities and projects, and balance workload and timelines.
  • Strong analytical and communication skills as well as fluency in English, both written and spoken.

As a person, you have a high degree of independence and are result-oriented. You are able to set strategic directions and make highly impactful decisions based on effective communication and close collaboration across multiple functions. Strong stakeholder management skills and a solution-oriented approach are essential for successfully driving projects and tasks in a timely manner. Most importantly, you are a lifelong learner and welcome the opportunity to develop new skills and gain further experience in patient-focused drug development.

About the department

The PFDD department consists of COA Scientific Director, COA Managers, COA Specialist, PFDD Professional as well as a Clinical Patient Preference Manager. We are passionate about bringing the patients' perspectives at the heart of everything we do and are proud of our inclusive and learning team culture. The team is committed to supporting each other in achieving professional development goals while also focusing on a balanced work life.

PFDD is part of Medical & Science Centre of Expertise. The purpose of Medical & Science Centre of Expertise is to connect the Medical & Science organization while driving scientifically sound medical deliverables across the Novo Nordisk project portfolio.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.

Contact

For further information, please contact Majbritt Ravn Hufeldt, Senior Director M&S, Patient-Focused Drug Development at +45 30756840.

Deadline

12 January 2025

Applications will be evaluated continuously when received, and candidates may be called for interview before the deadline.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in 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.

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