Regulatory Specialist – Clinical
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicines approved across the globe. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work but also challenging. Are you up for the challenge?
About the Department
RA-Inflammation & Growth Hormone is part of Regulatory Affairs and is a dedicated and diverse team of around 25 people. We are breaking new ground in a dynamic environment where our dedicated group prepares and executes the regulatory strategies and is responsible for global interactions with regulatory authorities. We work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. Together we go an extra mile to succeed.
The Job
The position is situated in Søborg and your role will consist of two elements. Acting as a competency anchor for the area, you will be our internal clinical regulatory specialist developing competencies and supporting regulatory clinical strategies internally in collaboration with line and project management. Together, we will look across the projects within the area and you will provide scientific sparring and oversight for the group of 5-8 clinical regulatory professionals. You will also be our representative on cross functional teams, share your knowledge and develop new ideas. In the other part of the job, you will support selected key projects where you will be responsible for securing clinical input to global regulatory strategies and submissions. You will plan, coordinate and review the clinical regulatory documentation and be our primary sparring partner for the clinical development organisation. To this end, you will work closely with the Regulatory Project Manager who is overall responsible for the regulatory part of our projects. You will report to the department director.
Qualifications
As a minimum, we expect you to have a biology/health science university degree plus regulatory experience from pharmaceutical development covering all stages of clinical development. Preferably, you hold a PhD or you can document similar solid scientific understanding. You have successfully worked in project teams respecting the contribution of everyone. You have demonstrated that you are organised, detail-oriented and a proactive problem-solver. You communicate well and are completely comfortable speaking and writing English and dealing with the challenges of international communication.
On a personal level, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions.
At Novo Nordisk, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.
Contact
For further information, please call Lars Wichmann Madsen +1 609-819-6572 (US East coast time).
Deadline
1 December 2013.
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicines approved across the globe. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work but also challenging. Are you up for the challenge?
About the Department
RA-Inflammation & Growth Hormone is part of Regulatory Affairs and is a dedicated and diverse team of around 25 people. We are breaking new ground in a dynamic environment where our dedicated group prepares and executes the regulatory strategies and is responsible for global interactions with regulatory authorities. We work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. Together we go an extra mile to succeed.
The Job
The position is situated in Søborg and your role will consist of two elements. Acting as a competency anchor for the area, you will be our internal clinical regulatory specialist developing competencies and supporting regulatory clinical strategies internally in collaboration with line and project management. Together, we will look across the projects within the area and you will provide scientific sparring and oversight for the group of 5-8 clinical regulatory professionals. You will also be our representative on cross functional teams, share your knowledge and develop new ideas. In the other part of the job, you will support selected key projects where you will be responsible for securing clinical input to global regulatory strategies and submissions. You will plan, coordinate and review the clinical regulatory documentation and be our primary sparring partner for the clinical development organisation. To this end, you will work closely with the Regulatory Project Manager who is overall responsible for the regulatory part of our projects. You will report to the department director.
Qualifications
As a minimum, we expect you to have a biology/health science university degree plus regulatory experience from pharmaceutical development covering all stages of clinical development. Preferably, you hold a PhD or you can document similar solid scientific understanding. You have successfully worked in project teams respecting the contribution of everyone. You have demonstrated that you are organised, detail-oriented and a proactive problem-solver. You communicate well and are completely comfortable speaking and writing English and dealing with the challenges of international communication.
On a personal level, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions.
At Novo Nordisk, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.
Contact
For further information, please call Lars Wichmann Madsen +1 609-819-6572 (US East coast time).
Deadline
1 December 2013.