Temporary Regulatory Assosiate in RA Modern and Human Insulins

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Odborní pracovníci v oblasti zdravotníctva a vied o živote
   Biológia a príbuzné profesie
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NÁPLŇ PRÁCE:

- Regulatory Affairs - Denmark - Søborg Join Regulatory Affairs and become part of a fast-changing environment where engaged people do their best every day to get Novo Nordisk’s medicines approved across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite challenging. We are currently looking for a Regulatory Associate (12 months temporary position) with an interest in working with Life Cycle Management (LCM) activities to join our Modern & Human Insulins department. About the department In the Modern and Human Insulins department we are 12 dedicated employees being responsible for all the regulatory LCM activities with clinical and/or labelling impact for the modern insulin products (Levemir®, NovoRapid® and NovoMix®) and human insulin products, marketed worldwide and used by millions of patients. We are organised in smaller product teams within the department, however we work in a flexible manner according to work load in the different product teams. The job You will be substituting for one of our six Regulatory Associates, and your primary task will be to handle the administrative tasks needed for clinical LCM of our human insulin products. You will work closely together with the product responsible Regulatory Professional, internal stakeholders and affiliates worldwide. You will be administratively responsible for preparing, compiling and submitting documentation to health authorities, and assisting in ensuring approvals. You will also be handling various requests from affiliates and other stakeholders. You will work in a fast paced environment with tight deadlines, and you will be supported by friendly colleagues with a good sense of humour. Qualifications Preferably, you have experience from working in Regulatory Affairs. You have an educational background as pharmaeconomist, medical secretary, bachelor in science, marketing, English or similar. You have a flair for IT systems and experience with MS Office applications as you will be responsible for managing data entry and electronic filing in our various databases and document management systems. Fluency in written and spoken English is a must. On a personal level, you are very structured, systematic and you have a strong quality mind-set. You are a team player, but also enjoy working independently. You have a positive attitude, good sense of humour, and you keep your spirits high also under pressure. At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Dorte Tingskov at +45 3075 8086. Deadline 6 September 2015.

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source: https://www.ec.europa.eu/eures

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