Clinical Submission Specialist
The Clinical team in Denmark is looking for an office-based Clinical Submissions Specialist. The team consists of office and field-based, dedicated and experienced colleagues who are working with global clinical activities, primarily on medical devices, in an international, dynamic environment.
As a Clinical Submissions Specialist, you will be part of the global clinical function and will be responsible for submission of clinical study documentation to regulatory authorities in Europe.
Your main responsibilities as a Clinical Submissions Specialist will be:
- Monitor and disseminate information on new or changed clinical investigation requirements in Europe, e.g., the ISO 14155, MDD 93/42/EEC and/or Regulation (EU) 2017/745.
- Support the development, creating and updating procedures, instructions, guidelines and systems within the department.
- 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.
- Maintain expert knowledge within submission of study documentation to regulatory authorities.
As a Clinical Submissions Specialist, you are expected to have the following qualifications:
- Bachelor or Masters preferably in a life science, nursing, pharmacy, medical or biomedical-related field or similar experience within science, healthcare or quality.
- Experience in submission of clinical study documentation or in clinical study management.
- Proven knowledge of the ISO 14155, MDD 93/42/EEC and/or 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 has a healthy company culture with a strong common set of values. Responsible, competent and professional staff is 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 to 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, as well as free use of the company’s own gym.
For further information about the job, please feel free to contact Rie Nomann Andreasen, Manager, Operations Support, Clinical Affairs by e-mail email@example.com.
Deadline for applications is February 4, 2018