Clinical Outcome Assessment Specialist
4 days ago
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Clinical Outcome Assessment Specialist - Parental Leave CoverCategory: Clinical Development
Location:
Søborg, Capital Region of Denmark, DK
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 Clinical Outcome Assessment Specialist in Medical & Science, Patient Focused Drug Development (PFDD). Apply today
This role is a one-year parental leave cover, based in Søborg, Denmark, where our team is located.
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 seeking an individual with expertise, passion, and experience in selecting, modifying, developing, and validating Clinical Outcome Assessments (COAs) to measure outcomes that matter to patients in clinical trials. This role focuses on aligning COAs with the product development plan, ensuring their implementation and interpretation meet the standards required for robust regulatory decision-making, while supporting evidence generation for labelling claims and patient-focused drug development.
As Clinical Outcome Assessment Specialist you will also:
- Plan, oversee, and report on in-trial patient interviews to develop and/or conceptualize a COA measure for regulatory use.
- Contribute to the development of COA dossiers and other regulatory briefing books when a product label claim (e.g., in the United States Prescribing Information and/or European Union Summary of Product Characteristics) is pursued based on a COA measure.
- Contribute to COA aspects of the clinical development program for regulatory decision-making at internal and external meetings with Product Development Committee, Product Development Council, Global Project Team, Medical Science Team, advisory boards, health authorities, and investigator meetings.
- Advise on the use of COAs in post-submission activities to allow successful life cycle management.
- Provide scientific support for congresses, symposia, and external collaborations related to COA.
Qualifications
To excel in this role, we require the following qualifications:
- A Master's degree in a relevant field such as health economics, pharmacy, public health, psychology, medicine, or epidemiology.
- Familiarity with collecting, analysing, and reporting qualitative and/or quantitative data.
- Experience in COA development and validation methods is preferred.
- Knowledge of clinical drug development and relevant regulatory guidelines is preferred.
- Excellent communication skills, both written and spoken, with fluency in English.
We are looking for a team player who can also work independently with a proactive mindset and a willingness to take action. You should be flexible and possess cross-cultural awareness, as well as the ability to adapt quickly to new situations in a continuously evolving environment. Being self-aware and well-balanced is also important. Above all, we value a lifelong learner who is eager to develop new skills and gain further experience in patient-focused drug development.
About the department
The PFDD department consist 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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