Submission Manager (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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Are you passionate about clinical trial submissions? Do you possess a talent for oversee-ing project management and ensuring compliance with global requirements? If so, we have an exciting opportunity for you to join our team as a Submission Manager at Novo Nordisk. This is a great opportunity to be part of defining our future processes and make a difference for clinical trials teams. Read more and apply today for a life-changing ca-reer.

The position
As a Submission Manager at Novo Nordisk, you will lead and be accountable for the submission of initial Clinical Trial Applications (CTAs) and amendments to Health Authorities (HAs) and Ethics Committees (ECs) in alignment with business needs and priorities. This new role has been introduced to strengthen the current process and establish a center of excellence. We are looking for 4 people to join our team, and these positions will be based in Søborg, Denmark. You will collaborate closely with various stakeholders across Development and Affiliate to ensure timely and compliant submissions on a global scale.

Your key responsibilities will include:

• Leading the CTA submission process effectively and applying best practices to en-sure timely submission of CTAs.
• Ensuring CTA submission is in compliance with all applicable requirements world-wide and driving better practice and consistency across trials.
• Coordinating the preparation and monitoring the compilation of CTA documents for submission of initial CTAs and amendments.
• Providing daily support to the team in analysis and problem-solving related to CTA submission activities.
• Providing continuous input to CTA process and system improvements to drive best practice and efficiency gains across CTA submissions.

Qualification
To succeed in this role, you should:

• Hold a Bachelor's or Master's degree in Life Science or a relevant field.
• Have experience within the pharmaceutical or medical device industry.
• Demonstrate project management expertise and experience in managing tri-als/projects.
• Exhibit experience in cross-functional organizational work, representing trial man-agement views.
• Possess extensive experience in all operational aspects of start-up, planning, con-duct, and finalization of CTAs.
• Be proficient in English.

As a person, you bring strong project management skills to the table, along with flexibility and cross-cultural awareness. You have the ability to inspire and motivate stakeholders, and your overall overview and analytical capabilities are exemplary. Moreover, your good communication, presentation, negotiation, and influential skills make you a valuable asset. Additionally, you possess the ability and willingness to adjust quickly to new situations in a continuously developing environment.

About the department
You will be part of a dynamic and dedicated team responsible for running all clinical devel-opment activities from initial planning of clinical trials towards authority submission. CTA Manage-ment is a department in constant development, and we are working closely with our stakeholders to continuously improve our processes to adapt and ensure compliance with the increasingly complex regulatory environment.
We offer interesting and challenging assignments and good opportunities for continuous personal and professional development.

Working at Novo Nordisk
At 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 experi-mentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufactur-ing, marketing and sales – we’re all working to move the needle on patient care.

Contact
For further information, please contact Henriette Westphal, Associate Director at +45 30752368.

Deadline
5 January 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. To ensure an efficient and fair recruitment.

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.