stillingsbetegnelse:
Regulatory/Technical Writer in Device Research and Development

jobbeskrivelse:
- Research & Development - Denmark - Hillerød Would you like to work in an R&D department, developing innovative medical devices? You will become part of our development team, where we are responsible for development, design, functionality and regulatory approval of injection devices on top-level internationally! About the department Device R&D is an area within our Global R&D organisation. We are responsible for the development of medical devices for self-treatment supporting all business areas of Novo Nordisk. Device R&D has a long and outstanding track-record of developing the best, most innovative and widely-used injection devices in the world. To learn more about Device R&D, please visit link: http://www.novonordisk.com/device-rd The position As our new Regulatory/Technical Writer, you are part of a cross-functional development team and work from the mid to late phases of our product development projects. Your main tasks involve preparation of complex regulatory documents for devices within Novo Nordisk different therapy areas. This includes test reports, device section of investigator’s brochures, summary documents and other documents covering interpretation and documentation of device data. As we cover all device development projects within Novo Nordisk different therapy areas, the focus and daily tasks depend on the type of document and the life cycle stage of the project. Planning and coordination of activities in a cross-disciplinary setting is also a central part of the job, and we expect that you are capable of driving the writing process and manage the involved stakeholders. The job is globally oriented and requires close collaboration with colleagues in other areas both in Denmark and internationally. Your main collaboration partners include device development specialists, clinicians, regulatory affairs and trial managers from Novo Nordisk headquarters. All documents are written in English and must comply with internal Novo Nordisk standard operating procedures as well as external guidelines. Qualifications You have a university degree within Engineering or natural sciences (M.Sc. or equivalent) including skills within statistics and scientific research methods. Preferably you have experience with writing technical/regulatory/medical documentation to be used for regulatory authorities, alternatively you have coordinated scientific articles, perhaps as first author. You should be master in both written and spoken English at a professional level, and you have a flair for, and a genuine interest in scientific communication. Experience with medical writing or technical writing from the pharmaceutical industry is a must. You are a strong team player who adapts easily to a changing environment with tight deadlines, and you have a flair for planning, coordinating and reaching consensus with your stakeholders. You are thorough, structured and conscientious, and you have a good sense of humour. In return, we offer an interesting and challenging job with a significant amount of individual responsibility in an international and dynamic atmosphere. Working at Novo Nordisk In Device R&D we use our skills, dedication and ambition to help people with chronic diseases, and change their lives. You will get the opportunity to take part in this, and in addition enhance your career, benefiting from the possibilities for professional and personal development provided by Novo Nordisk. Contact For further information, please contact Søren Mikkelsen at +45 3079 4851 or Rasmus Klinck at +45 3079 8754 Deadline 19 June 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Andet ingeniørarbejde (undtagen elektroteknologi)

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark