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: RA Associate III
Job Desciption
About the department
Regulatory Affairs Operations (RAO) is a transaction centre supporting RAHQ DK and RA in business Regions different business processes like RIMS Data Management, Publishing, Graphical Designing etc., with about 50 regulatory professionals.
Regulatory Information Management System (RIMS) is an IT system used by Novo Nordisk A/S to handle and maintain registration status information on a country by country basis for all drug products and medical devices in Novo Nordisk A/S for countries with registration requirements and supports regulatory business processes, registration maintenance, order generation, batch allocation and batch releases.
The team RIMS Data Management Professionals currently handle tasks related to registration data in RIMS database in collaboration with RAHQ DK & RA in business regions. An extensive part of activities involves maintaining Regulatory data of Novo Nordisk products, and making sure that the Regulatory changes are updated & implemented in time and support batch releases to the markets.
The Job
You will be responsible for Data Entry for Regulatory changes & updates and ensure high quality in data entry in accordance with defined KPI's and SOP’s and internal guidelines/policies; daily maintenance and control of data in RIMS system and securing quality of existing data. Continuous collaboration with RAHQ DK and RA in business regions through mails, tele conferences etc. , do follow-ups and record the internal work flow data into internal data tracking system, to enable the jobs traceability, KPI Reports etc., as per the procedures. Work as per targets and timelines, support the team as per business requirements & be a good team player, able to understand required process quickly, actively involved in cross functional activities, responsible for sharing better practices, responsible for own continuous development.
Daily operational business has to comply with defined KPIs and SOPs. There is a limited degree of independence; however as innovation is critical in respect to LEAN including continuous improvement, you are expected to be proactive and take an active part in the daily operations.
Candidate Profile
Relevant academic degree at minimum bachelor level e.g. Graduation in Science, Pharmacy/computer science. Professional skills include Data Entry & Data Management, Knowledge in Regulatory Affairs, Regulatory Affairs Documentation, and Knowledge in Register Database preferred; 2 to 3 years relevant work experience, strong skills on service culture and delivery.
Proficiency in oral and written English is essential together with a high degree of integrity.
The job requires cultural awareness and the ability to communicate with stakeholders with diverse cultural backgrounds.
Additional Information:
Qualification: M.Pharm
Location: Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Post Date: 3rd July, 2015
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