Medical Communication Specialist
We are looking for
To ensure continued clinical expertise as an integrated part of the product lifecycle, Cook Medical is looking for a Medical Communication Specialist for its Regulatory Affairs department.
You will join a team of 29 dedicated colleagues working with regulatory activities worldwide. We work closely together with other colleagues in the fields of development, clinical research, manufacturing, quality and marketing as well as with colleagues of our main office in the US.
In Regulatory Affairs, we primarily provide support to the business units, Aortic Intervention, Critical Care, Interventional Radiology and Peripheral Intervention. You can learn more about our business units on www.cookmedical.eu.
Your main responsibilities as a Medical Communication Specialist will be:
- Preparation and maintenance of Clinical Evidence Reports
- Provide input to Postmarket Surveillance, including postmarket literature search and clinical advice on marketed devices
- Participate in product development projects, providing the clinical input, e.g., clinical design requirements, risk analysis, instructions for use and clinical trial strategy
- Collaborate with internal and external regulatory colleagues on writing clinical documentation for submissions worldwide (e.g., Europe, the US, Japan, China, Australia)
- Prepare clinical assessments in connection with postmarket vigilance
- Perform clinical review of marketing material (e.g., instructions for use, brochures, and presentations)
- Gaining and maintaining product expertise and a solid understanding of internal procedures and clinical regulatory requirements
As a Medical Communication Specialist, you are expected to have the following qualifications:
- A clinical education or other relevant scientific educational background, e.g., a degree in Life Science, Pharmaceutical Science or other relevant background
- Proven skills of analyzing and presenting scientific data and literature searches
- Preferably, experience from working in the medical device or pharmaceutical industry
- Preferably, knowledge and understanding of regulatory requirements for medical devices
- Excellent verbal and written communication skills in English and Danish
You have an eye for detail while still the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. It is obvious that you work independently within your own areas of responsibility. Importantly, we expect you to be an excellent team player with a positive and committed approach to your tasks. You have excellent communication skills at all levels and the wish for working in a global, yet local environment.
Cook Medical’s company culture is based on a set of strong common values where 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 humor 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.
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.
If you would like further information about the position, please contact Mie Dyrholm, Team Lead PI/IR/CC, Regulatory Affairs by phone: +45 56 86 84 92 / e-mail: firstname.lastname@example.org.
Please mail your application with references and CV to Birte Nielsen, Human Resources Generalist, Recruitment, at email@example.com, no later than December 9, 2016.
Please state in your application where you’ve seen the vacancy.
Cook Medical is a leader in researching, developing and manufacturing medical technologies that improve quality of life for patients around the world. To provide our customers with the best possible support, we have en strategic business units that each specializes in a particular segment of medicine. Products are manufactured on three continents and are distributed to 135 countries.
We currently employ around 800 people in Denmark, William Cook Europe, Sandet 6, 4632 Bjaeverskov