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Senior/Principle Medical Writer - MDR
☞ PharmiWeb.jobs: Global Life Science Jobs
View: 139
Update day: 21-02-2024
Category: Education / Training
Industry: Staffing Recruiting
Position: Director
Job type: Full-time
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Job content
Hobson Prior are looking for a Senior/Principle Medical Writer - MDR to join an excellent global healthcare company on a permanent basis, located in Switzerland. Our Client is focused on making healthcare more accessible to all and advance it in a meaningful way.Please note that to be considered for this role you must have the right to work in this location.Key Responsibilities- In this position you will be responsible for creating scientific and regulatory documents in accordance with the highest quality standards with a cross-functional team.
- Perform, prepare, and maintain clinical evaluation reports in compliance with EU Medical Device Regulations (MDR) and related guidance documents (e.g. MEDDEV.2.7./1 Rev. 4).
- Prepare regulatory submissions for the EU, US, and other international markets by analysing safety and performance data for medical devices.
- Support the preparation, conduct, and reporting of clinical investigations and other PMCF activities by writing and reviewing regulatory documents.
- Writing in a clear, concise scientific style; paying attention to details to produce high-quality results.
- Self-motivated and organized with project management skills to manage a multi-product writing portfolio of projects.
- A Bachelor or Master of Science degree (required) or higher (preferred).
- Medical/scientific writing experience of at least 5 years and 7-10 years in the pharmaceutical/medical device industry.
- Supervise multiple external vendors and contingent workers.
- Knowledge of scientific literature and state-of-the-art data analysis.
- Understanding of biostatistics and Haemonetics’ products/medical background.
- Strong English language skills, German or other EU language a plus.
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Deadline: 06-04-2024
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