Safety Medical Writer
- Quality
- 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. 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
This is a permanent job as a Safety Medical Writer in Safety Surveillance Reporting at Novo Nordisk A/S. In this role, 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 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 Terrie Ramirez +45 3079 7385.
Deadline
6 January 2014.
- Quality
- 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. 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
This is a permanent job as a Safety Medical Writer in Safety Surveillance Reporting at Novo Nordisk A/S. In this role, 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 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 Terrie Ramirez +45 3079 7385.
Deadline
6 January 2014.
