stillingsbetegnelse:
Internship in Regulatory Affairs, Affiliate Coordination

jobbeskrivelse:
- Student & Internship - Denmark - Søborg Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. At Novo Nordisk, we share a passion for changing patients’ lives, and we are always looking for talented individuals who want to join us in this effort. Our internships provide exciting learning opportunities for students who bring new ways of thinking to our company. About the department You will have the opportunity to work with a high performance team, where we manage regulatory requests from all over the world. In close collaboration with key stakeholders in our sister departments in affiliates, we ensure that we are in compliance with rules and regulations from the local health authorities. We provide the needed documentation and samples for submission to health authorities, and we coordinate packaging material creation for launches and updates to ensure correct product information in local language to the patients in our therapy areas within diabetes management and hormone therapy. We work cross-functionally and bridge the local health authorities’ requirements with our production units globally. The job You will support several key optimization and compliance projects in the department. One of the current projects is aiming at strengthening the way we plan updates to patient information material (leaflets, cartons and labels) and ensure that the updated material reaches our patients in a timely manner. This information material is of outmost importance to the patients as wrongly dosing or incorrect information can have severe consequences for the patient safety. Rules and regulations are changing globally and at the same time, Novo Nordisk product portfolio is expanding, which makes it increasingly difficult to be in compliance with all demands globally at the same time. Your role in this project will be to collect, structure and systematize information about local health authorities’ demands to patient information material and help innovate how Novo Nordisk can meet these requirements in a simple and sustainable way. The information will be collected through interviews with our regional and local offices, through surveys and through research of country-specific rules and regulations. At the same time, you will provide a similar research support to other projects in the department. Qualifications We are looking for an intern who can handle diverse information and is able to systemise complex data. You are currently studying on your master’s degree in pharmacy, public health, health services research, health economics, economics or other relevant field, and you like to handle multiple data sets. General knowledge of research-related disciplines and key methodologies (database analysis, systematic literature reviews and excel analysis) is needed. We expect candidates to be service-minded, thrive in a busy environment and bring a can-do attitude. Fluency in both oral and written English, ability to manage a large volume of data (with supervision), sound personal judgment and excellent interpersonal skills are required. You pay attention to details and you have a strong analytical mind-set. You are not afraid to challenge your interviewee if the documentation or analysis reveals incompleteness or inconsistent logic. You are happy to work in an international environment with tight deadlines, and you are proactive in reaching out to stakeholders if you identify challenges. ou have a healthy sense of humour – also under pressure. Finally, you have strong work ethics and a willingness to take responsibility for your tasks and own learning. Practicalities Qualification: Students in their first or second year of their master studies Period: The internship position is a full-time position

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

land: Danmark

region: Hovedstaden

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark