Principal Medical Writer Medical Devices
2 weeks ago
Opportunity to join a 100% Medical Device-focused CRO and offer technical leadership with the preparation Clinical Evaluation Reports (CERs).
**The Company:**
An international CRO that accelerate product development through integrated laboratory, clinical and consulting services. They provide holistic support to clients from development to commercialization. Now in a period of growth, they are seeking experiencedwriters to join and be instrumental in the next phase of the business.
**Principal Medical Writer Role:**
- Lead and oversee the process of preparing documents that conform to EU MDR regulatory requirements (Instructions for Use, Technical Documentation, Clinical Evaluation Reports, Labelling, SSCP, PSUR, etc.)
- Project manages the writing process.
- Responsible for quality checking documents before approval.
- Attends stakeholder meetings (internal and external) about documents in development.
- Supports communication strategy development.
100% Remote
**Principal Medical Writer Requirements**:
- BSc, MSc or PhD in life sciences or a related field
- 4/5+ years of Medical Writing experience in preparing CERs (MEDDEV 2.7.1 Rev 4) under EU MDD, AIMD or MDR
- Comfortable working in a regulated industry that demands tracking changes to regulatory requirements.
If this role isn't what you're looking for don't worry. At X4 Communications we cover all permanent and contract positions, with specialist industry sector teams. You can check out all of our roles on our website and sign up for job alerts so you're thefirst to know about a new opportunity.
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