Clinical Outcome Assessment Specialist
5 days ago
Select how often (in days) to receive an alert: Create Alert
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.
#J-18808-Ljbffr-
Clinical Outcome Assessment Specialist
5 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeWould 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...
-
Data Governance Specialist
23 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Data Governance Specialist to join our R&D Data Governance Office at Novo Nordisk. As a Quality & Compliance Partner, you will play a key role in overseeing quality and compliance initiatives related to Data Governance.Your primary responsibilities will include driving initiatives that support the identification,...
-
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeAre you an experienced Medical Writer looking to grow your career? If yes, then we would love to hear from you. The position As Medical Writing Specialist, your main responsibility is to drive the preparation of complex clinical documents and act as project manager. More specifically, you are expected to lead tasks such as: Planning, development and...
-
Senior Director
5 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Senior Director - Diabetes & Obesity Clinical Operation Category: Clinical Development Location: Søborg, Capital Region of Denmark, DK Do you have a passion for leadership and want to be part of a journey building on our strong portfolio and influencing our future operating model in Clinical...
-
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Søborg, Denmark Jobkategori Clinical Development Are you passionate about innovative Clinical Drug Development with a keen eye for Haemoglobinopathies? Would you drive change for patients with Rare Diseases and relish the chance to be medically responsible for the clinical development strategy for a clinical-stage asset for...
-
Medical Specialist
2 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeAre you a medical doctor with experience and passion for clinical drug development and at the same time keen on designing and executing clinical trial programs? Are you committed to making a difference for patients with new and innovative treatments? Then, this is your chance to be part of a team of talented medical doctors in a great and inspiring working...
-
International Medical Director
5 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Søborg, Denmark Jobkategori Clinical Development Ansøg nu Are you passionate about finding new solutions for rare Hemato-renal diseases? Do you possess extensive experience in clinical development and a deep understanding of how immunology impacts these conditions? If so, we are looking for an International Medical Director...
-
Herlev Kommune, Denmark Københavns Universitet (KU) Full timeDepartment of Clinical Medicine Faculty of Health and Medical Sciences University of Copenhagen The University seeks to appoint a clinical professor of Internal Medicine: Nephrology with special focus on Chronic Kidney Disease and Mineral Bone Disorder to commence as soon as possible. The externally funded professorship is combined with a consultancy at...
-
CMC Regulatory Affairs Specialist
13 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleAs a CMC Regulatory Specialist at Novo Nordisk, you will provide strategic, tactical, and operational regulatory input to projects. You will lead activities for synthetic small molecule projects in late development as well as drive scientific and regulatory discussions across our portfolio.In this role, you will work closely with stakeholders...
-
Regulatory Affairs Professional
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeRole Summary:We are seeking a highly skilled Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist to join our team at Novo Nordisk A/S.In this role, you will be responsible for providing strategic regulatory input to projects, including developing regulatory strategies for submission of clinical trial applications (CTAs) and marketing...
-
Safety Surveillance Specialist
5 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeCategory: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you want to lead and drive safety surveillance activities in development projects in rare diseases? And would you like to be part of one of the most skilled and advanced pharmacovigilance functions in Denmark? Then, this might be a great opportunity for you...
-
QA Specialist for Validation
5 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu Would you like to play an important role in ensuring the quality and safety of products for clinical trials, where you can use your solid QA and validation experience in a project context? Then we can offer you a unique position with a lot of responsibility and impact in a dynamic...
-
CMC Regulatory Specialist
5 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK We are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic...
-
Data Governance Framework Specialist
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionThe Data Governance Coordinator will play a pivotal role in shaping and executing the data governance framework, ensuring its seamless integration into ongoing initiatives. This position will be part of the Data Governance team within the Data & AI Governance department.Key Responsibilities:Operationalize Data Governance: Develop and implement...
-
Outsourcing Manager
5 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Søborg, Denmark Jobkategori Procurement Ansøg nu Are you motivated by the opportunity of being part of an ambitious clinical outsourcing team? Do you understand the pharma business, have a strategic mind-set and strong communication skills as well as an interest in working with suppliers in the clinical drug development space?...
-
Senior Product Owner
7 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeAre you an experienced leader with a passion for managing product innovation in a dynamic, global environment? We are seeking a Senior Product Owner to join our Operational Data Insights (ODI) team and drive the delivery of digital products that support Novo Nordisk’s mission to be a world-leading manufacturer of treatments for chronic diseases. Apply...
-
Global Medical Director for Obesity Solutions
13 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a seasoned medical professional to join our team as an International Medical Director for Obesity Solutions. As a key member of our clinical development team, you will play a crucial role in driving the planning and design of clinical studies, providing medical oversight during study conduct, and interpreting data.This is an...
-
Pharmacovigilance Lead
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout Pharmacovigilance at Novo NordiskWe are a leading pharmaceutical company seeking an experienced professional to lead and drive safety surveillance activities in development projects for rare diseases.As a key member of our Global Safety team, you will be responsible for establishing product safety profiles during clinical development and performing...
-
Regulatory Specialist
7 days ago
Vejle kommune, Denmark Vectura Fertin Pharma Full timeJob Details: Regulatory Affairs Senior Specialist Job Title: Regulatory Affairs Senior Specialist Vacancy No: VN1967 Category: Clinical, Medical and Regulatory Affairs Contract Type: Permanent Contract Duration: Full Time Location: Vejle Job Advert: Fertin Pharma has ambitious plans to grow our business in established markets (North America and...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a Senior Quality Specialist to join our team in Novo Nordisk A/S's R&D Quality Operations department. The ideal candidate will have a strong background in quality assurance, regulatory affairs, or clinical research, with a focus on In-Vitro Diagnostics.In this role, you will be responsible for providing quality assurance support...
