At Novo Nordisk Research & Development, GD GSC, our trust in our employees has always been one of the cornerstones of the way we work. Working here, you’ll be part of a team of the best and brightest in your field, where scientific integrity is standard and shared responsibility taken for granted. We use our skills, dedication and ambition to make a change in the lives of many people with chronic diseases in our own way. 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.
Requisition ID – 46171BR
Title – Safety Medical Writer
About the Department:
Global Safety: The department the Global Service Centre responsible for processing ICSRs and for performing Safety Surveillance activities. Global safety has an outstanding track-record in case processing and writing/publishing aggregate reports. You will join a team of highly motivated employees, responsible for the safety of the patients.
The job is a permanent position and starts ASAP – latest 01 Jul 2017.
You will become a member of the safety surveillance team which is responsible for aggregate reporting. You will especially focus on defining and integrating user/stakeholder requirements and safety risk management. You will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance your professional and personal development, providing you with an opportunity to develop skills within specialist expertise and project management.
- Plan, drive, and co-ordinate preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with Regulatory affairs.
- Contribute to continuous resource planning process in collaboration with immediate superior – including identifying medical writing tasks and assist in prioritisation of tasks
- Perform consistency review of documents as back-up SMW
- Act as mentor/trainer for other safety medical writers working with the product, as required.
- Perform medical writing tasks in Safety Surveillance including planning and preparation of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs/PBRERs), Risk Management Plans (RMPs)
- Responses to any safety questions raised in connection with assessment reports
- Input to – investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs), and investigational medicinal product dossiers (IMPDs) and other relevant ad-hoc documents
- Medical Doctor, Dental doctor, Master degree in pharmacy or equivalent medical and scientific background.
- Experience with scientific writing in English (publications or equivalent)
- Specific personal and job-related demands (communication skills, ability to take initiative, flexible attitude, ability to work independently/in a team, personal traits necessary in the job, etc.).
- Open and honest
- Systematic and organised
- Goal oriented
- Good team player
- Good at sharing knowledge