Novo Nordisk Hiring Clinical Publisher in Global Development bachelor’s
degree in Pharmacy, Science, IT, Engineering
The position
As a Clinical Publisher you are responsible to perform compilation
and publishing of clinical documents including but not limited to Clinical
Trial Reports (CTRs), Investigator’s Brochures (IB), Non-intervention Study
Reports (NSRs), Clinical summaries and overviews etc. Plan the collection of
appendix material in collaboration with the study group as applicable for the
relevant clinical documents to ensure appropriate appendix material is in
compliance with GCP, Novo Nordisk SOPs and international guidelines and support
document owners through sharing knowledge about content requirements, as well
as the use of novoDOCS and other requirements such as scanning standards to
publish clinical documents (as required) according to current Novo Nordisk
standards for regulatory publishing.
Ensure quality control of published output is performed according to
current Novo Nordisk standards for regulatory publishing to ensure distribution
of final documents according to valid SOPs also make sure legacy documents are
indexed into novoDOCS for regulatory submissions as applicable for the relevant
clinical documents. Also you need to ensure electronic quality control (eQC) of
clinical documents is performed according to current Novo Nordisk standards for
regulatory publishing at relevant timelines and support the organisation in use
of novoDOCS and clinical templates.
The Clinical Publisher needs to cooperate and communicate with
colleagues from many departments within headquarters and in the affiliates and
Clinical Development Centres to ensure timely collection of required
documentation and must be service minded, a good team player and able to work
effectively across language and cultural differences.
Qualifications
You are expected to have the below skills and knowledge:
Post-graduate (Pharmacy, Science, IT, Engineering) or relevant
bachelor’s degree
Minimum 2 years of relevant experience in the routine use of
Document Management Systems, MS Office, Portable Document Format (PDF) tools
including Adobe Acrobat Professional and ISI toolbox
General knowledge and understanding of FDA, ICH and other regulatory
electronic documentation requirements
Ability to communicate, plan and coordinate multiple simultaneous
activities
Excellent communication and stakeholder management skills
Ability to communicate with people from different professional and
cultural backgrounds
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