Principal GCP Advisor

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Søborg

Do you dream of using your solid Good Clinical Practice (GCP) knowledge, due diligence experience, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Would you like to be a central part in the due diligence and integration activities in potential and actual partnerships and acquisitions? Do you want to be part of a dynamic area where you are expected to take ownership and responsibility for setting the right quality level? Apply today and join us for a life-changing career. The position We are expanding and are looking for a new Principal GCP Advisor in the Clinical Compliance department, in R&D Quality. 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. You will be responsible for shaping and optimising the framework for the clinical quality role in due diligence and integrations. In this position you will 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. Qualifications To succeed in this role, you have:
  • A degree in pharmacy, medicine, science or similar
  • Solid experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations
  • Experience within clinical quality assurance, trial management/monitoring, or GCP Audits
  • It is preferred that you bring experience from due diligence and integrations
  • Strong written and verbal communication skills in English
  • On a personal level you take a positive and pragmatic approach to problem solving and you are eager to create, optimise and simplify processes around you. You are proactive, courageous and have strong communication and interpersonal skills. You are organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. You are a team player but can work independently and you thrive working across departments in 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 activities when looking at and acquiring new assets
  • Providing GCP support globally and leading 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. We are on an exciting journey bringing quality on top of the agenda throughout the R&D organisation. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our careers is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Lene Tommerup at +45 3075 7779 or Lisbeth Bonefeld at +45 3075 8096. Deadline 19 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 27.1.2023, 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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