Principal GCP Advisor

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Søborg

Do you dream of using your solid GCP (Good Clinical Practice) knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Have you worked with due diligence and integrations or wish to work with this area, and will you bring a ‘can-do’ attitude to support high quality in the development of innovative treatments for patients? Then join us as our new Principal GCP Advisor and be a part of our expanding team! Don't miss this opportunity—submit your application today! The position
The open position is in our Clinical Compliance department. Here we support the development area in many aspects of clinical quality, and there is now a stronger need for support in due diligence and integration activities in potential and actual partnerships and acquisitions. In close collaboration with other functional areas, you will be the GCP and clinical quality voice in the due diligence process and later also supporting and ensuring a smooth and well integration process of the acquired assets into our organisation. The role entails taking responsibility for shaping and optimising the framework for the clinical quality role in due diligence and integrations. In this position, you may also be involved in other activities in the department such as improvement/optimisation projects, quality partner for a key project/line of business and supporting our stakeholders with GCP advice. You will be part of a dynamic area, where the position offers high impact, and where you are expected to take ownership and responsibility for setting the right quality level in the global organisation. Qualifications
A successful candidate is expected to have a Master’s degree in pharmacy, medicine, science, or a relevant field, coupled with +7 years of experience in clinical research and drug development. In addition to the above, you need to show the following:
  • Solid knowledge of GCP and other relevant regulations
  • Track record within clinical quality assurance, trial management/monitoring, or GCP Audits
  • Proven experience from due diligence and integrations is preferred
  • Good understanding of drug development
  • Excellent written and spoken English
  • Personally, you approach problem-solving with a positive and practical mindset, always seeking opportunities to optimise and simplify processes. Your proactive and courageous nature is complemented by your excellent communication and interpersonal abilities. Additionally, you possess a strong sense of organisation and attention to detail without losing sight of the broader picture. Your commitment to quality is unwavering, and your innate curiosity drives your continuous learning. You excel as both a collaborative team member and an independent worker, thriving in cross-departmental collaborations within an international organisation. About the department Clinical Compliance is one of three sister departments in Clinical Quality & Compliance, which is part of R&D Quality in Novo Nordisk. We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes. In Novo Nordisk, we have an ambitious drug development program, and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society. In Clinical Quality & Compliance, we support the development organisation and drive many activities such as:
  • Being Clinical Quality partners to key projects and line of business
  • Taking part in due diligence and integration activities when looking at and acquiring new assets
  • Providing GCP support globally
  • Leading the GCP inspections
  • Reviewing and approving audit CAPA plans
  • Performing vendor assessments and trying to impact external clinical requirements and sharing clinical Quality and GCP knowledge to the global organisation
  • We also take active part in cross organisational improvement projects and provide general quality & compliance support to our global organisation. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Lene Tommerup +45 3075 7779
    Deadline
    31 December 2023. We will be screening, interviewing, and hiring on an ongoing basis. 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 5.10.2023, 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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