Principal GCP Advisor Specialist
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Søborg
We are expanding and are looking for a principal GCP advisor for our Clinical Compliance department. Do you dream of using your solid GCP knowledge, integration experience, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Have you worked with integrations, and will you bring a ‘can-do’ attitude to support high quality in the development of innovative treatments for patients? Then you could become our new principal GCP Advisor. Read below and apply now! Role waiting for you
As a Principal GCP Advisor you will have high impact, and you are expected to take ownership and responsibility for setting the right quality level in the global organisation. In close collaboration with other functional areas, you will be the GCP and clinical quality voice in the integration process, ensuring a smooth integration of the acquired assets into our organisation. This could for example include: Assessment of standard operating procedures and how to integrate them into the Novo Nordisk quality management system Shaping and optimising the framework for the clinical quality role in integrations Participating in improvement/optimisation projects, being quality partner for a key project/line of business and supporting our stakeholders with GCP advice You will be part of a dynamic and hybrid team with colleagues mainly working from Denmark but also from other countries. Our office sits in Denmark, and we meet once a year, but we will consider how to accommodate you no matter from where in the world you apply. Skills we look for To be successful in this role you should have: A degree in pharmacy, medicine, science, or a related field At least 7 years experience in clinical research and drug development Experience in clinical quality assurance, trial management/monitoring, or GCP audits (with preferred experience in integrations) Solid understanding of GCP and other relevant regulations Strong command of written and spoken English As a person you are: Representing positive and pragmatic approach to problem solving, eager to create, optimise and simplify processes around you Proactive, courageous and have strong communication and interpersonal skills Organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature Team player, but thrive working independently as well as working across departments in an international organisation
Team waiting for you In this role you will join the Clinical Compliance team. It is one of four sister departments in Clinical Quality, 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, 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 integration activities when acquiring new assets providing GCP support globally leading the GCP inspections reviewing and approving audit CAPA plans Ensuring processes and standard operating procedures are in compliance with external and internal requirements performing vendor assessments and trying to impact external clinical requirements We also take active part in cross organisational improvement projects and provide general quality & compliance support to our global organisation. We are busy and are on an exciting journey bringing quality on top of the agenda throughout the R&D organisation – and maybe you are the one to join us on this journey? Join Novo Nordisk family
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change
to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing
massively and expanding our commitment, reaching millions around the world and impacting
more than 40 million patient lives daily. All of this has made us one of the 20 most valuable
companies in the world by market cap. Our success relies on the joint potential and collaboration
of our more than 63,000 employees around the world. We recognise the importance of the
unique skills and perspectives our people bring to the table, and we work continuously to bring
out the best in them. Working at Novo Nordisk, we’re working toward something bigger than
ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life
changing. Contact
For further information, please contact hiring manager Malene Wibe Alexander +45 30752464
Deadline
1 September 2024 Applications will be reviewed on an ongoing basis, so please apply 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. 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.
As a Principal GCP Advisor you will have high impact, and you are expected to take ownership and responsibility for setting the right quality level in the global organisation. In close collaboration with other functional areas, you will be the GCP and clinical quality voice in the integration process, ensuring a smooth integration of the acquired assets into our organisation. This could for example include:
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change
to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing
massively and expanding our commitment, reaching millions around the world and impacting
more than 40 million patient lives daily. All of this has made us one of the 20 most valuable
companies in the world by market cap. Our success relies on the joint potential and collaboration
of our more than 63,000 employees around the world. We recognise the importance of the
unique skills and perspectives our people bring to the table, and we work continuously to bring
out the best in them. Working at Novo Nordisk, we’re working toward something bigger than
ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life
changing. Contact
For further information, please contact hiring manager Malene Wibe Alexander +45 30752464
Deadline
1 September 2024 Applications will be reviewed on an ongoing basis, so please apply 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. 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 15.8.2024, 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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