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Reg Affairs & Safety Pharmacovigilance

Are you adept at planning, coordination, problem-solving, and collaboration across the organization? Do you boast experience within clinical trial activities? Are you ready to take charge of operational clinical trial application (CTA) activities across the Novo Nordisk portfolio of projects and products? Then you might be the individual we are seeking in CTA Management.

Apply now and carve your place in an exciting environment where driven individuals are dedicated to securing approval of Novo Nordisk’s Clinical Trials across the globe.

The position
As an Associate Regulatory Professional for CTA Management at Novo Nordisk, you will have the opportunity to:

  • Foster cross-organizational collaboration and provide operational support to stakeholders in headquarters and affiliates.
  • Utilize your expertise in CTA local requirements to ensure compliance and successful submission to local authorities.
  • Participate in continuous improvement activities and projects within the department and across the organization, contributing to the development, optimization, and standardization of the CTA process.

Qualifications
From a successful candidate, we expect the following competencies:

  • A M.Sc. within natural sciences or a similar background (e.g., pharmaconomist, laboratory technician), or B.Sc. within natural sciences or a similar background with relevant experience working within Regulatory Affairs or Clinical Development/Clinical Operations
  • A quality mindset with excellent overview, planning, and coordination skills.
  • Strong communication and presentation skills
  • Experience with IT systems and MS Office applications
  • Fluent in written and spoken English.

It will be considered an advantage if you have:

  • More than 2 years of experience working within Regulatory Affairs or Clinical Development/Clinical Operations
  • Previous experience in the pharmaceutical industry
  • Knowledge/experience of work with guidelines and content.

On a personal level, you thrive in a busy environment and bring a positive can-do attitude to your work. You are outgoing, a strong team player and enjoy working in a diverse working environment with various stakeholders globally and across the organization.

About the department
CTA Management is a centralised unit in Regulatory Affairs, and we are responsible for coordination and planning the CTA packages across all trials in Novo Nordisk. We provide the CTA packages to the affiliates worldwide to ensure they can submit to get approval at their local authorities.

You will be located in Søborg and join a team of seven other colleagues, who is handling all the CTA packages to make them available for the affiliates and/or the EU submission Hub.

CTA Management 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 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.

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

Deadline
12 May 2024

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 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.

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