Require Clinical Publisher in Global Development at Novo Nordisk
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post : Clinical Publisher in Global Development
The key responsibilities in this position will be to perform compilation and publishing according to relevant Standard Operation Procedures (SOPs) and guidelines 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. You will be ensuring that clinical documents delivered to Regulatory Affairs are submission ready by performing Electronic Quality control (EQC) of all relevant documents including but not limited to trial protocol, Statistical Analysis Plan (SAP), CTRs, IBs, NSRs, analytical reports, clinical summaries and overviews etc.. in this role you will support the organisation in use of novoDOCS and clinical templates and contribute to knowledge sharing, skill building and good collaboration with stakeholders and colleagues.
• 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
• Team player with a high degree of flexibility
• Analytical, solution oriented and ability to multitask and prioritise activities
• Live up to Novo Nordisk Way
• Excellent communication and stakeholder management skills
Qualification : M.Pharm, M.Sc
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global Development
End Date : 15th April, 2020
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