Clinical Submission Specialist
The Clinical team in Denmark is looking for an office-based Clinical Submission Specialist. The team consists of office and field-based, dedicated and experienced employees working with global clinical activities, primarily on medical devices, in an international, dynamic environment.
As a Clinical Submission Specialist, you will be part of the global clinical function and be responsible for submission of clinical study documentation to regulatory authorities in Europe.
Your main responsibilities as a Clinical Submission Specialist will be to:
- Monitor and disseminate information on new or changed clinical investigation requirements in Europe, e.g., ISO 14155, MDD 93/42/EEC and Regulation (EU) 2017/745
- Be responsible for submission of clinical study documentation to regulatory authorities in Europe in alignment with regional and local country requirements
- Support clinical study teams globally in creating the clinical submission package and adapting it to regional and local requirements
- Support clinical study teams globally in interpretation of regional and local regulations on submission and approval of clinical studies in Europe
- Support the development, creating and updating procedures, instructions, guidelines and systems within the department
- Maintain expert knowledge within submission of study documentation to regulatory authorities
As a Clinical Submission Specialist, you are expected to have the following qualifications:
- Bachelor or Master, preferably, in a life science, nursing, pharmacy, medical or biomedical-related field or similar experience within science, healthcare or quality
- Experience of submission of clinical study documentation to regulatory authorities
- Proven knowledge of ISO 14155, MDD 93/42/EEC and Regulation (EU) 2017/745 as well as applicable international standards and other regulatory requirements that may impact clinical studies
- Excellent verbal and written communication skills in English and Danish
You have an eye for detail and the ability to juggle multiple tasks in a thorough and systematic manner.
It is obvious that you work independently within your own areas of responsibility. More importantly, we expect you to be an excellent team player with a positive and committed approach.
Cook Medical’s company culture is based on a set of strong common values. Responsible, competent, and professional employees are our most important resource.
We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty, and humour are highly appreciated. The staff of Cook Medical helps uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide
- we make a difference every day.
Cook Medical offers a well-organized internal training course which is taken by all new staff to enable them to quickly gain thorough knowledge of the company.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, and free use of the company’s own gym.
Contact Rie Nomann Andreasen, Manager, Operations Support, Clinical Affairs by phone: +45 21 22 85 68 or e-mail: Rie.firstname.lastname@example.org.
Applications must be submitted no later than March 3, 2019.