Job as Document Controller 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: Document Controller 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.
The main job task in this role is to distribute safety reports and Investigator’s Brochure (IB) to Novo Nordisk clinical trial sites globally through CONNECT- Novo Nordisk Investigator Portal. In this role you will participate in knowledge sharing and skill building activities to maintain good collaboration with stakeholders and ensure active participation in relevant meetings, training sessions and seminars in the department locally/globally.
The role is based in GD GSC, Bangalore, India but travel may be required locally or to Novo Nordisk offices in Denmark or affiliate offices for business related meetings/conferences. The role doesn’t have a direct influence on any of the internal or external stakeholders. The ability to work in a global context is important, as well as cultural awareness and inclusive approach.
You are expected to have the below skills and knowledge.
* Bachelor’s degree in Pharmacy/Life Science (4-year course)
* Minimum 6 months of relevant experience in web based Document Management Systems, MS Office and Portable Document Format (PDF) tools
* General knowledge and understanding of FDA, EMA, ICH GCP and other regulatory electronic documentation requirements for safety reporting
* Ability to communicate, plan and coordinate multiple simultaneous activities
* Fluent in English language (read, write and speak)
* Team player with a high degree of flexibility
* Ability to multitask and prioritise activities
* Demonstrate Novo Nordisk leadership competencies
* Good communication and stakeholder management skills
Qualification : B.Pharm, B.Sc
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Development & Medical
End Date : 15th December, 2019
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