Position
Do you have a strong background in non-clinical activities? We
are looking for a Non-Clinical Expert to join our team at Novo
Nordisk. If you are ready to contribute to the development,
submission, and approval of new drugs/devices, and have a passion
for maintaining existing products, then read on and apply today
for a life-changing career!
About the department
Novo Nordisk is a global healthcare company with more than
100 years of innovation and supervision in diabetes care. This
heritage has given us experience and capabilities that also enable
us to help people defeat serious chronic
diseases.
Non-clinical Expert works within the Clinical
Department but will be in charge of non-clinical
activities on development, submission and approval of new
drugs/devices, and maintenance of existing products through
generation of documentation with sufficient quality aligned with
local non-clinical requirements and other external and internal guidelines.
The position
As a Non-Clinical expert, you will ensure the high-quality
preparation of J-CTD (M.2.4. and 2.6) in collaboration with HQ.
While most modules are Japanese translations of HQ's CTD, you must
thoroughly have knowledge on each module's content
and verify its accuracy. Module M2.6.2 is prepared by Novo Nordisk
Japan or outsourced based on study reports. Additionally, you'll
be tasked with preparing high-quality responses to inquiries from
PMDA (Pharmaceuticals and Medical Devices Agency) in partnership
with HQ, requiring accurate understanding and communication of
inquiries to HQ, though the majority of responses are prepared by
them.
Other role expectations include:
Qualifications
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it.
We’re a dynamic company in an even more dynamic industry, and we
know that what got us to where we are today is not necessarily
what will make us successful in the future. We embrace the spirit
of experimentation, striving for excellence without fixating on
perfection. We never shy away from opportunities to develop, we
seize them. From research and development, through to
manufacturing, marketing, and sales – we’re all working to move
the needle on patient care.
Contact
Upload your CV to our online career page (click on Apply and
follow the instructions).
Deadline
Until the completion of recruitment.
Applications will
be screened on an ongoing basis, so you are encouraged to apply as
soon as possible.
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.
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