Medical Writer İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
If you have a LIFE SCIENCE background and a way with words, this job fits for you…
We are seeking junior or senior medical writers to support the development and creation of Clinical, Scientific, and Regulatory documents (such as CEP, CER, PEP, PER, PMCF, SSCP etc.) in accordance with MDR EU 2017/745, IVDR EU 2017/746 and related guidance documents
This includes
· Conducting literature reviews,
· Assisting and writing Clinical Evaluation plan & Reports (CEP & CER),
· Analysis of product complaints and trends,
· Collecting and analyzing feedback from various sources to support the CER, PMCFs, Clinical Protocols.
Required Skills
- Advanced English is a must (reading, writing and speaking)
- Strong time management skills with the ability to manage multiple competing priorities
- Bachelor’s / graduate degree in Bio Engineering, Genetic Engineering or other 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
- Resilient, oriented, flexible, self-confident, good team player
- Able to handle stressful and fast-paced tasks
- Interpersonal and communications skills,
- Energetic, positive attitude across hard tasks and feed-backs
- 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.
Preferred Skills
- High level of Bio-Statistic Analysis experience
- Master or PhD degree in related fields,
- Experience in writing scientific thesis/articles
Desired Skills
- Good knowledge of ICH-GCP and quality activities in clinical studies
- Experience in clinical studies
- GMP knowledge
- Standard quality management system experience (ISO)
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