Regulatory Decision-Making Specialist
4 days ago
We are passionate about connecting the Medical & Science organization while driving scientifically sound medical deliverables across the Novo Nordisk project portfolio. 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 Role
You will plan, oversee, and report on in-trial patient interviews to develop and/or conceptualize a COA measure for regulatory use. You will contribute to the development of COA dossiers and other regulatory briefing books when a product label claim is pursued based on a COA measure.
You will also 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.
Key Responsibilities
- 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 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.
- 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.
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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