Trial Master File Development Professional for Trial Management (temporary)
- NOVO NORDISK A/S
- 11. januar 2019
- 20. januar 2019
Data and Trial Management is looking for a Competency Development Professional starting as soon as possible. In this job, you will be offered exciting opportunities to increase your experience within processes, system-related aspects and training around the Trial Master File (TMF) as well as taking part in change management initiatives.
In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the processes live up to uniform global standards, regulations, and business ethics. We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society.
About the department
The Trial Management Anchor is part of Global Development and our main responsibility is supporting our trial management organisation in competency development, knowledge sharing and process optimisation related to clinical trials. In addition, we own a number of the clinical processes and work with the organisation to ensure these always live up to requirements and are implemented consistently across the global organisation.
As Competency Development Professional, TMF, you will be part of the Trial Management Anchor playing a key role in handling the TMF training requirements, meeting internal and external requirements and developing new ideas for improvement of the way we work. The position is located in Søborg, Denmark.
Furthermore, you will be involved in oversight of the TMF activities, supporting the implementation of new processes. You will be an important stakeholder for the global TMF super user network. On a day-to-day basis, you will be collaborating with a wide range of stakeholders across the organisation.
You are experienced in the processes of clinical trials and especially strong within GxP requirements. As a minimum, you have a Master's degree within relevant scientific areas, and it is an advantage if you have experience within clinical operations and document management.
We expect you to be committed, loyal and service-minded, and act with a strong sense of responsibility. You are known for showing an open mind, a positive attitude and clear overview despite many activities with high complexity, ambitious targets and numerous stakeholders. You are a master at analytical, training and change management skills. Additionally, you must possess solid IT skills and work in a structured manner with a sense for quality and details, while also being able to maintain the helicopter view.
It is essential that you can act independently, but also as a team player who thrives on contributing to any team you are a part of. You have the ability and willingness to adjust quickly to new situations in a continuously developing environment. Fluency in written and spoken English is essential.
Working at Novo Nordisk
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.
For further information, please contact Jeannett Dimsits at +45 3079 6604.
18 January 2019.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.