If you have a life sciences background and a way with words, this job fits for you…
DeSia Clinical & AdviQual is providing regulatory and quality solutions to medical device companies.
We are seeking junior or senior medical writers to support the development and creation of Clinical, Scientific, and Regulatory documents in accordance with procedures and European Medical Device Regulation.
Conducting literature reviews,
Assisting and writing Clinical Evaluation Reports (CER),
Analysis of product complaints and trends,
Collecting and analyzing feedback from various sources to support the CER, PMCFs., Clinical Protocols,
Analysis of statistical data regarding device
Following regulatory changes
Advanced English (reading, writing and speaking)
Strong time management skills with the ability to manage multiple competing priorities
Bachelor’s / graduate degree in Bioengineering, Genetic Engineering or similar Engineering / Life Sciences degrees from reputable universities, hoping for a career in the medical device industry and clinical affairs sector
Really ambitious to learn, conduct research and follow-up
Goal oriented, highly flexible, dynamic, self-confident, good team player
Able to handle stressful and fast-paced tasks
Interpersonal and communications skills,
Energetic, positive attitude across hard tasks,
Did we mention Good command of English? Yes, indeed we are serious about it since every research and composing report is going to be in Scientific English.
Flexible to relocate - Crucial on the job training is going to be given at our office in Beylikdüzü.
Master or PhD degree
High level of Bio-Statistic Analysis experience
Good knowledge of ICH-GCP and quality activities in clinical studies
Experience in clinical studies
Standard quality management system experience (ISO)
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