- Regulatory Affairs
- Bangalore
Looking for talented Regulatory Affairs professionals !
Are
you a person with innovative thinking and proactive attitude with
continuous improvement as one of your career objectives? Join
Publishing Support Team at Novo Nordisk and get a life-changing career!
About the Department
Publishing
Support & RA Technical check, GSC Bangalore is a part of Regulatory
Operations. The team works closely in collaboration with Novo Nordisk
HQ Denmark, United States & other Novo Nordisk Affiliates across the
world. The Publishing & RA Technical check team ensures to compile
& publish reviewer friendly Regulatory dossier. which in turn get
submitted to various Health Authority for registration of Novo Nordisk
product. We also provide publishing support for life cycle management of
Novo Nordisk product.
The Job
This position will support RA Technical check.
You
will be responsible for ensuring compliance of publishing ready
documents so that when these documents go for eCTD, NeeS publishing
there should not be any showstopper elements. You will also be
responsible to check the Published output as per the provided table of
contents. Critical check should be done for PDF format, Bookmark
information, Hyperlinks, etc.
In
addition you are also responsible to support regulatory dossier
publishing in eCTD, NeeS, Paper & other national format. The
publishing task will be done with the help of software dedicated for
publishing.
Qualifications
Relevant
academic degree at minimum masters level in life sciences eg. Master of
Pharmacy, Master of Sciences. Professional skills include working
knowledge in PDF reader & PDF writer; strong ISI Tool & Adobe
Acrobat knowledge (MS Office applications); working knowledge in eCTD
publishing tool & experienced in dossier compilation. 1 to 2 years
of experience in regulatory dossier compilation is mandatory.
Proficiency
in oral and written English is essential. The job requires cultural
awareness and the ability to communicate with stakeholders with diverse
cultural backgrounds.
“At
Novo Nordisk, we create value by putting patients first. Every ten
seconds two people are diagnosed with diabetes, and more than 371
million people worldwide need us. Working here is not just a way to make
a living, but a way to make a difference.”
Contact
For further information please contact Surajit Roy on +91 9591996412.
Deadline
11 July 2014APPLY