Submission Specialist (Maternity cover)

Job title: Submission Specialist (Maternity cover)

Company: Novo Nordisk


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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading…CategorySelect how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Submission Specialist (Maternity cover)Category: Clinical DevelopmentLocation:Ørestad, Capital Region of Denmark, DKDo you want to be part of a dynamic, virtual team managing clinical trial start-up activities across several countries? Would you like to use your experience to continuously optimise the way trials are launched? Are you prepared to embrace and tackle challenges as part of your daily work? If your answer to these questions is ‘yes’, read on. We are now looking for a Submission Specialist to join us for a one year position within Clinical Development Centre (CDC) in Denmark!The PositionIn this role you will be responsible for managing and overseeing the lifecycle of Clinical Trial Applications (CTA) for all trials in Denmark, from first submission to approval, including managing and submission of modifications. You will:

• Ensure timely planning, high-quality preparation, and submission of Clinical Trial Applications (CTA), modifications, and related documents in compliance with EU Clinical Trials Regulation (CTR), including follow-up and responding to Request For Information (RFI)
• Plan, prepare and collect documents for part I and part II and secure that national documents for Part I and Part II are provided and matched to the EU national content plan as per agreed timeline with EU CTR team

• Liaise with CRA, start-up TM/CDC TM and start-up specialist, to ensure all relevant (site) documents are available in time for EU CTR submission and RFI
• Ensure timely translation, review and adaptation of local documents in local language as per local requirements (incl. Informed Consent)
• Maintain overview of local requirements incl. local site requirements and part II templates issued by local authority/IEC
• Ensure timely update of relevant systems such as Vault Clinical and VaultRIM

QualificationsThe Submission Specialist position requires excellent organizational, communication and project management skills, as well as a strong understanding of the EU CTR process.Demonstrating and fostering a team culture of best practice sharing, providing innovative solutions, and openness to share learnings are essential for this role.Additionally, you are our ideal candidate if you:

• Hold a degree within life science or healthcare and knowledge of the clinical trials environment and ICH GCP
• Have in-depth experience and knowledge in lifecycle management of Clinical Trial Applications as per EU Clinical Trials Regulations, and in regulatory legislation and processes (Denmark and EU) relating to clinical trials
• Can understand and decipher new legislation or process to assess business impact
• Good working knowledge of electronic clinical trials systems
• Have experience from similar role in the pharmaceutical industry or Clinical Research Organisation
• Have strong problem-solving skills, a can-do attitude and the ability to prioritise tasks
• Work independently while also being a dedicated team player
• Are a native Danish speaker with high proficiency in English (oral and written)
• Can demonstrate independence, innovation, and initiative by proactively identifying potential issues, utilizing creative problem-solving approaches and prioritizing tasks effectively until pressure and time constraints

About the DepartmentAs the Submission Specialist, you will belong to a team that consist of a mixed group of specialists in start-up activities, reporting to the head of study start-up. The Clinical Development Centre (CDC) Denmark is responsible for managing back-office activities, such as project management and administrative tasks on clinical trials across eight countries (Austria, Belgium, Denmark, Finland, Ireland, Norway, Sweden and Switzerland). The CDC-DK is a part of the DK affiliate.CDC Denmark as project-centric organisation becomes the backbone in clinical trials for all Therapy Areas, while leading across seven countries, as well as Denmark. Together with our colleagues across the value chain in Head Quarter (HQ) and adjacent affiliates, we ensure through scientific evidence that we can provide safe and efficacious treatment to people living with diabetes and other chronic diseases.We value an open, trust-based, and creative working environment as well as a great team spirit. Our working environment is characterised by interesting and demanding assignments and continuous professional development opportunities.Working at Novo NordiskAt Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.ContactIf you have any questions, please contact Hanne Verstraete, Head of Study Start-up, at [email protected].DeadlineApply before 31st July 2025.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 resume or CV.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

Expected salary:

Location: Ørestad, København

Job date: Sun, 13 Jul 2025 07:07:38 GMT

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