stillingsbetegnelse: Safety Medical Writer

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd Are you interested in drug safety and pharmacovigilance writing? Do you want to be part of a department that keeps patients safe? Then we definitely want to hear from you! About the department Safety Surveillance Reporting is responsible for aggregate safety reporting on the surveillance of adverse reactions reported for marketed products and products under development at Novo Nordisk A/S. We are a dynamic, well-functioning, international team of 10 Safety Medical Writers and 6 Safety Publishers, and 6 Safety Data Analysts. We work together to coordinate, prepare, and electronically publish all key safety surveillance reporting documents. As we work in a rapidly changing regulatory landscape, where the global requirements for reporting on pharmacovigilance activities are still evolving, change-readiness and out-of-the-box thinking are both invaluable assets. The Job As a Safety Medical Writer in Safety Surveillance Reporting at Novo Nordisk A/S, you will be responsible for planning and managing the process for document preparation in a cross-functional environment, soliciting relevant information from stakeholders for different areas across Novo Nordisk A/S, and being overall responsible for writing high quality documents. You will typically work in close collaboration with Safety Surveillance Advisors, Medical Specialists from Global Development, Medical Advisors from Medical Affairs, Project Managers from Regulatory Affairs, and Safety Publishers. While your key responsibilities will include preparing the key safety reporting documents (including Development Safety Update Reports, Periodic Safety Update Reports, and Clinical Risk Management Plans), you will also be expected to actively contribute to continual process improvements and other improvements projects. Qualifications You have a university degree (MD, PhD, MSc or equivalent) with a demonstrated a flair for, and genuine interest in scientific communication in English (publications or equivalent). Experience from the pharmaceutical industry and pharmacovigilance in particular, are a major advantage, but not a must. Strong project management and inter-personal skills are a pre-requisite for the role as Safety Medical Writer as co-ordinator and writer in the multi-disciplinary teams. You must be good at planning, coordinating, and reaching consensus. You are able to work independently, but at the same time you are a strong team player who adapts easily to a changing environment and tight deadlines. As all our documents are written in English, you must be fluent in both written and spoken English. Good attention to detail is important for reviewing documents, and for spotting important details amongst large volumes of data. You are thorough, structured and conscientious, and you have a good sense of humour. Experience with LEAN or similar is an advantage for contributing to continuous process improvement. 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 Mark White: +45 3079 6710. Deadline 27 March 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark