Medical Writer

1 week ago

England, United Kingdom European Medical Writers Association (EMWA) Full time

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Pharmacovigilance Special Interest Group (PV SIG)
As part of the growing interest amongst medical writers in safety writing, and also based on the understanding that there are subtle differences between safety writing and medical writing, EMWA is introducing a PV SIG.
Medical Devices Special Interest Group (SIG)
A forum for EMWA members to discuss and share information in the area of medical and vitro devices
At Haemonetics, we develop innovative medical technology products and services that improve the quality, effectiveness and efficiency of care. We are building a collaborative, performance-driven culture that attracts and develops the best talent. 
Joining our team, you'll serve as a vital link between clinical expertise and regulatory requirements. Your role will involve crafting scientific and regulatory documents, collaborating with cross-functional teams to ensure adherence to the highest quality standards. Specifically, you'll be responsible for creating and maintaining Clinical Evaluation Reports (CERs), in alignment with EU Medical Device Regulations (MDR) and related guidance documents. Your tasks will also encompass conducting structured literature searches, analyzing clinical data, and developing study protocols and safety plans.
Additionally, you'll play a key role in supporting Medical Affairs and Regulatory Affairs in devising and executing regulatory strategies. We're looking for candidates with a Master's degree or PhD in Science (biology, biochemistry), Biomedical Engineering, Diagnostics, or Medical Technology. A minimum of 7 years of experience in the medical device/pharmaceutical industry, with at least 5 years in medical/scientific writing, is required. Experience in writing CERs (Clinical Evaluation Report) is paramount.
The ideal candidate will possess a clear, concise scientific writing style, attention to detail, and proficiency in conducting literature reviews and data analyses.
Strong project management skills, the ability to manage multiple writing projects, and excellent language skills are essential (in English and preferably another European language).
Work-life balance environment
Take part in building the Scientific affairs department
Career opportunities
Remote policy: 2 days remote/week

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