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Department – Clinical Reporting Unit
Does your motivation come from challenges and working in a
dynamic environment? Do you thrive in a working environment
where close collaboration with key stakeholders and strategic
alignment is essential? Do you have a can-do attitude with
continuous improvement as one of your career objectives? Then
we might have the right position for you. Apply now and join a
growing team, working in an international environment.
About the department
The Clinical Reporting unit in GBS has seen a tremendous
growth curve and has become an integral part of the Global
Clinical Reporting community in a short span of 6-7 years,
since its inception in 2011. The team is a dynamic mix of
enthusiastic and qualified skilled Medical Writers, Disclosure
Medical Writers, Publishers and Document Controllers with
Masters/PhD in life sciences, pharmacology, medicine, etc. The
team is full of commitment, passion, skills, and talent with
broad knowledge on different therapeutic areas and regulatory
requirements for submissions. The team has an average
experience of 7-8 years in writing and reviewing regulatory
documents and publications. We use our scientific expertise to
drive clear and impactful communication on the conduct and
outcome of clinical trials. Apart from writing and publishing
regulatory documents, the team is also responsible for
distribution of documents (CONNECT portal) and largely
contributes to NN’s regulatory commitments by being involved
in Public disclosure activities.
The Position
As a Senior Medical Writer you will ensure timely, clear,
and proactive communication and collaboration with the
stakeholders and colleagues globally. Furthermore, you will
communicate across the time zones and in different
professional environments. This job requires good
communication and analytical skills. In order to meet
timelines, you must be good at planning own work and be
proactive when problems arise and seek help and advice from
relevant people within GBS as well as within Head Quarters
(HQ). Additionally, you will challenge the expert contributors
on the clinical documents where the quality of their written
contribution could be improved. You are entrusted to fulfil
the following responsibilities:
- You will be performing medical writing tasks for trial
and/or non-trial activities within clinical reporting
including but not limited to preparation of Protocols,
Clinical Trial Reports (CTRs), Non-interventional study
reports (NSRs), Layperson Summary (LPS), Investigator
Brochure (IB) and Regulatory response documents (Q&A). - You will have to communicate the clinical data in a
clear and concise manner. - You will contribute to knowledge sharing and maintain
good relationship with the stakeholders and colleagues.
Qualification
- You are expected to have the below skills and knowledge:
- Post-Graduate (PhD, MSc., M Pharm, MD, DDS, DVM or equivalent)
- 5+ years of experience as medical writer or other
relevant work experience - Experience working within a global setting
- Experience from the pharmaceutical /CRO industry
- Strong understanding of external requirements related to
regulatory documents - Good communication skills
- Works independently on smaller tasks
- Strong analytical skills
- Committed, persistent and accountable
- Able to plan and manage variable workload
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
To submit your application, please upload your CV and
motivational letter online (click on Apply and follow the instructions).
Apply Now!
Deadline
30th Jan 2023
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.
