stillingsbetegnelse: Safety Surveillance Technical Publisher

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd Do you thrive in a dynamic, international environment with multiple tasks and tight deadlines? Do you have strong skills within IT? Do you have focus on structure and quality? Then you may be our new Technical Safety Publisher. About the department Safety Surveillance Reporting is responsible for preparing regulatory reports and related documentation reporting on surveillance of adverse reactions 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, 6 Safety Publishers and 6 Safety Data Analysts. We work closely with other functional areas across Novo Nordisk (incl. Global Safety, Regulatory Affairs, and Clinical Development) to coordinate and prepare high quality key safety documents submitted to health authorities. As we work in a rapidly changing regulatory landscape, where global requirements for reporting on pharmacovigilance activities are still evolving, change-readiness and out-of-the-box thinking are invaluable assets. The job Key safety reporting documents (Development Safety Update Reports, Periodic Safety Update Reports, and Clinical Risk Management Plans) must be submitted to regulatory authorities in high quality and easily navigable electronic format in accordance with current external and internal guidelines. As a Technical Safety Publisher you will be responsible for compiling, structuring and publishing documents in electronic format using the Novo Nordisk document management system, novoDOCS (based on DOCUMENTUM), and Insight Publisher. You will also be responsible for performing electronic format QC of documents and English language QC (in accordance with writing style guides). You will be actively involved in optimising existing business processes via innovative IT solutions. Moreover, you will drive the development of novoDOCS Word style templates, including troubleshooting and repairing documents. Finally, you will provide training, technical support and solutions for novoDOCS issues as well as ad hoc IT Support to the Safety Surveillance area. Qualifications The Technical Safety Publisher must hold a master’s degree in information sciences, Computers, IT, Engineering, or other relevant area. Applicants must have excellent IT skills and an ability to apply this knowledge to drive business process improvements. Experience with document management systems and publishing tools/systems is a pre-requisite. Additionally, experience with content management systems (especially SharePoint) and citation management systems (e.g. EndNote) is an advantage. The Technical Safety Publisher position requires good planning/coordination skills and a strong quality mind-set with attention to detail. You must be able to maintain a broad overview while juggle diverse tasks; have a systematic and structured approach to solving tasks, be flexible in your approach to your work, and be able to accommodate tight deadlines. IT Project management experience is an advantage. Pro-active thinking, accountability, and willingness to continuously develop personal and technical skills are important assets. In a day-to-day setting, you are acknowledged as a team-player with good spirit and a can-do attitude. 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 Anders Reinholdt Thunell at +45 3075 2746. Deadline 11 September 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Systemanalytikerarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark