Experienced Medical Technical Writer with ambitions for your field
Vacante de Autores y otros escritores en Dinamarca (HOVEDSTADEN)
Clasificación del trabajo:Profesionales científicos e intelectuales : Profesionales en derecho, en ciencias sociales y culturales : Autores, periodistas y lingüistas : Autores y otros escritores. Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for jura, samfundsvidenskab og kultur : Forfatterarbejde og journalistisk og sprogvidenskabeligt arbejde : Forfatterarbejde.
Descripción de la oferta de trabajo:
-?Research & Development -?Denmark - Hillerød Are you a looking forward to take your career to the next level and a new direction? Are you looking for a great opportunity to work closely with new product launch and have close interaction with the authorities and ensuring final touch of products? Join Novo Nordisk to obtain key experiences and get a life-changing career and make a difference to thousands of lives! 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 In Device Development (DD), we develop innovative devices that add value to patients and Novo Nordisk. Our obligation is to support the Device R&D Strategy by maximising the value of current device portfolio within diabetes, growth disorder, haemophilia and new therapies. We bring device projects from development candidate to launch readiness. In the team we are 7 people currently working on submitting documents to health authorities and getting ready for launch in the US and EU. You will be joining the team in giving the necessary documents the final touch and support answering to the questions of health authorities. The position To ensure submission readiness of new medical devices, you will prepare submission packages to health authorities ensuring that documentation is compiled and communicated appropriately. For instance, you will prepare HFE usability test reports, Regional Medical Advisor (RMA) documentation, labelling and other relevant ad-hoc documents. It is an important part of the job to guide the development engineering colleagues on their documentation, participating in the project teams as the expert on documentation and written communication with regulatory authorities. This is a great opportunity to work close to new product launches and close interaction with authorities ensuring final touch of products. You will collaborate widely across Novo Nordisk with stakeholders across our Research & Development organisation as well as our Product Supply organisation. Qualifications As a Medical Technical Writer, you hold a Master of Science or equivalent. As a minimum you have 2 year of experience with scientific research methodology and with regulated industries like pharma/aerospace/automotive or food. You have a documented high professional level of experience with scientific writing in English (publications or equivalent). Preferably, you have experience with medical device regulations and interaction with regulatory and health authorities. In addition, the right candidate probably has previous work experience from health authorities from medical/technical writing or from regulatory affairs positions. Quality mind-set is key to be able to ensure consistent and high quality deliverables. To be successful in this role, you must have a crucial eye for details and scientific communication with a high degree of solution orientation and drive to complete tasks within deadlines. You will enjoy collaborating across skill areas and share knowledge to enhance competences with colleagues. Working at Novo Nordisk At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Martin Paulsen at +45 3079 1095. Deadline 13 August 2017.
Servicio de empleo de origen:AMS, Servicios Públicos de Empleo, Dinamarca.