Outcome Measurement Specialist

4 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Novo Nordisk A/S is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. As a Clinical Outcome Assessment Specialist, you will be part of this ambitious journey towards ensuring that patients' experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation.

This role is a one-year parental leave cover, based in Søborg, Denmark, where our team is located. We are seeking an individual with expertise, passion, and experience in selecting, modifying, developing, and validating COAs to measure outcomes that matter to patients in clinical trials.

About the Department

The PFDD department consists of COA Scientific Director, COA Managers, COA Specialists, PFDD Professionals, and 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, which connects the Medical & Science organization while driving scientifically sound medical deliverables across the Novo Nordisk project portfolio.

Responsibilities

  1. Plan, oversee, and report on in-trial patient interviews to develop and/or conceptualize a COA measure for regulatory use.
  2. Contribute to the development of COA dossiers and other regulatory briefing books when a product label claim is pursued based on a COA measure.
  3. Contribute to COA aspects of the clinical development program for regulatory decision-making at internal and external meetings.
  4. Advise on the use of COAs in post-submission activities to allow successful life cycle management.
  5. Provide scientific support for congresses, symposia, and external collaborations related to COA.

Requirements

  • 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.


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