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UDLØBET

Novo Nordisk

Associate Regulatory Professional for CTA Management

Fuldtid

Permanent

Gladsaxe

SE PÅ KORT
ID: 2580417
|
Indrykket for 15 dage siden

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.

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