Specialist, Medical Communication, Regulatory Affairs
Are you our new Medical Communication Specialist, and are you interested in working in a busy, ambitious and inspirational environment?
To ensure continued clinical expertise as an integrated part of the product lifecycle, we are looking for an additional colleague to the team, with a clinical or scientific background, ideally with previous experience of medical writing.
As a Medical Communication Specialist in Regulatory Affairs, you will join a team of 30 dedicated colleagues working with regulatory activities worldwide. We work closely together with other colleagues from different departments in the fields of development, clinical research, manufacturing, quality, Post-Market Surveillance, and marketing as well as with colleagues of our main office in the US.
In Regulatory Affairs, we provide support to the Vascular and MedSurg business divisions within the specialty areas, Aortic Therapies, Venous Therapies, Peripheral Artery Disease Therapies, Embolic Therapies and Critical Care. You can learn more about our business divisions at www.cookmedical.eu.
Your main responsibilities as a Medical Communication Specialist will be:
- Preparation and maintenance of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER). The CER demonstrates the safety and performance of our devices and compiles clinical data, medical literature assessments as well as risk and complaints data and is kept updated throughout device lifecycle
- Provide a summary of the relevant, published clinical literature as input to Post-Market Surveillance, including post-market literature search and clinical advice on marketed devices
- Participate in product development projects, providing the clinical input, e.g., clinical design requirements, risk analyses, instructions for use and clinical trial strategy
- Collaborate with internal and external regulatory colleagues on writing clinical documentation and reply to questions from competent authorities for submissions worldwide
- Perform clinical review of marketing material (e.g., instructions for use, brochures, and presentations)
- Gain and maintain product expertise and a solid understanding of internal procedures and clinical regulatory requirements
To be successful in this role, you will need to have an interest in systematically seeking and interpreting clinical literature, and a genuine interest in writing and presenting large amounts of data.
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, Nurse with scientific experience, and, preferably, a PhD or similar degree
- Preferably, previous experience of medical writing and of communicating scientific information in collaboration with different stakeholders
- Proven skills of analyzing large amounts of data and presenting scientific data
- Experience of preparing systematic 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.
Regulatory Affairs operates in a global environment which requires excellent communication skills and a flair for collaborating at all levels. You are organized and have an eye for detail while still the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. You are self-driven and work independently within your own areas of responsibility, and you are able to handle changes in prioritization of tasks. Importantly, we expect you to be an excellent team player with a positive and committed approach to your tasks. You wish to work in a global, yet local environment.
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 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 - every day, we make a difference.
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 Mie Dyrholm, Manager Venous, PAD, Embolic Therapies and Critical Care, Regulatory Affairs by phone: +45 56 86 84 92 or e-mail: Mie.Dyrholm@cookmedical.com or Karin Nielsen, Manager Aortic Therapies, Regulatory Affairs by phone: +45 56 86 88 86 or e-mail: Karin.Nielsen@cookmedical.com.
Deadline for applications is July 28, 2019, and shortly after this date, the first interviews will take place.