stillingsbetegnelse: Safety Medical Writer

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd Are you looking for an opportunity to get into drug safety?. Are you a good coordinator, and do you like scientific writing? Then this 12 month temporary position may be just the break you need! About the department Safety Surveillance Reporting is globally responsible for preparing risk management plans, periodic aggregate safety reports on surveillance of adverse reactions reported for all Novo Nordisk products. We are an agile, well-functioning, international team of 12 professional Medical Writers (10 in Denmark and 2 in India) and 6 publishers (4 in Denmark and 2 in India). We work in multi-disciplinary teams, typically interacting with representatives from all major functions across Novo Nordisk. The role of the department is to ensure the preparation of high quality scientific documents that are compliant with regulatory guidelines, ensuring ongoing transparent reporting, evaluation and management of the emerging safety profile of drugs – both while under development and after marketing. 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 In this 12-month temporary position as 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 high quality scientific writing. 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 an advantage. Strong project management skills and inter-personal skills are a pre-requisite for the role of 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 A/S, 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 Samuel Ramsden +45 3075 5727 or Marcus Schartau +45 3075 6713. Deadline 17 January 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark