Novo Nordisk is a healthcare company with a leading position within the area of diabetes, haemophilia, growth hormone disorders and women’s health. As an employee at Novo Nordisk you will have the potential to make a significant difference to patients, the medical profession and society.
Post : Clinical Publisher in Global Development
About the department
The Medical Writing unit 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. It is a dynamic mix of young, enthusiastic, qualified and skilled Medical Writers and Publishers who are full of commitment, passion, skills and talent. The team is a right blend of professionals with Masters/PhD in pharmacology, medicine, toxicology etc. with broad background knowledge on different therapeutic areas and medical basics. The team has an average experience of 7-8 years in writing and reviewing regulatory documents and publications.
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.
• 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
Experience : 2 years
Qualification : M.Pharm, MSc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global Development
End Date : 5th September, 2020
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