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 : Senior Associate - RIMS Data Management
Job Description
About the department
Global Regulatory Affairs (GRA) in Bangalore consists of eight departments that work across our global processes and support both colleagues in Head Quarter Denmark (DK) as well as colleagues in our affiliates all over the world. As the area is growing, the total area will by midyear 2019 consist of approximately 120 dedicated employees. Regulatory Operations, Global Business Services (GBS) is an integral part of Regulatory Operations, Denmark (DK). The objective of this team is to ensure efficient and competitive Regulatory Operations to support Regulatory Affairs Headquarters (HQ) and Regulatory Affairs (RA) Affiliates. The team provides the services in Submission Management, Regulatory Information Management and operational graphic design.
The position
• As a Senior Associate, you will be responsible for data entry in Regulatory Database (RIMS) for Registrations, Regulatory changes and updates. You need to complete the tasks as per targets and timelines by ensuring 100% quality in data entry. and you would be handling and addressing the queries of stakeholders.
• Furthermore, you should have proactive approach regarding system and business process improvement and also be responsible for verification of registrations in data approval workflow and make sure you will be archiving the approval letters in archival system.
Candidate Profile
• Graduate/post graduate or Comparable degree in Science/ Pharmacy/ computer related field
• 2-4 Years relevant experience
• Knowledge in Data Entry & Data Management
• Knowledge in Regulatory Affairs
• Knowledge in Register Database preferred
• Knowledge in MS-Office
• Readiness for handling other tasks
• Good Communication Skills
• Good subject knowledge in academics
• Detail oriented
• Active in self-development
• Is service minded and customer oriented
• Demonstrates a high-quality mind set
• Ability to work in teams
• Ability to, in peak periods, work under tight deadlines and under a high work load
• Focuses on targets and delivers results
• Act proactively
• Readiness to changes
Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : RIMS Data Management
End Date : 25th May, 2020
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