Associate Regulatory Professional for CTA Management
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Søborg
Associate Regulatory Professional for CTA Management Would you like to drive operational clinical trial application (CTA) activities across the Novo Nordisk portfolio of projects and products? Are you inspired by planning, coordination, problem solving and collaboration across the organisation? Then we offer you this interesting position with opportunities for continuous personal and professional development. Apply today and join us in Søborg for a life-changing career. The position As our new Associate Regulatory Professional, you will facilitate cross-organisational collaboration and provide operational support as well as CTA local requirement expertise to our stakeholders in headquarters and affiliates. You will also have the opportunity to be involved in continuous improvement activities and projects within the department and across the organisation for developing, optimising, and standardising the Novo Nordisk CTA process. Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s Clinical Trials (CTs) across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work. Qualifications To succeed in this role, we expect you to have: A B.Sc. within natural sciences or other relevant background (e.g., life or health science, or similar) Preferably minimum 2 years of experience working within Regulatory Affairs or Clinical Development/Clinical Operations Flair for IT systems and experience with MS Office applications Strong communication and presentation skills and fluent in verbal and written English As a person you have a quality mind-set and excellent overview, planning and coordination skills, and you enjoy working in a structured way to meet tight deadlines. You are motivated by taking the lead and 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 organisation. About the department CTA Management is a centralised unit in RA, and we are responsible for coordination and planning the Clinical trial application (CTA) packages across all trials in Novo. We provide the CTA packages to the affiliates worldwide to ensure they can submit to get approval at their local authorities. For CTAs running in EU have we recently created a new team within CTA Management who is supporting submissions and approvals, as part of implementation of a new EU Clinical trial Regulation. They are called the EU Submission Hub and is a virtual team, with people sitting across EU countries and in India. You will join a team of 5 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 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. Contact For further information, please contact Fi With Gjessø at +45 30777812. Deadline 26 February 2023. We shall conduct interviews on an ongoing basis, so please submit your application as soon as possible. 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 10.2.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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