€30 - €45
3 months ago
6 - 12 months
Medical / Regulatory Writer
Fully Remote -- 6 – 12 months contract
Full time – 40 hours/week
Hamlyn Williams has partnered with a multinational company looking for a medical writer to be an integral part of the client organisation group that is implementing the European Medical Devices Regulation (MDR) for disposable and electromechanical devices. You will need to review, assess, and update the risk management documents.
As a Medical Writer, you will be required to:
- Manages the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- Works closely with the study team writers to ensure timelines and deliverables are met
- Completes document reviews according to agreed-upon timelines and follows up with the study team writers as needed to meet internal and external timeline commitments and procedural and regulatory requirements
- Updates project-related tracking tools
- Maintains records for all assigned projects, including archiving
- Schedules and conducts document-related meetings, including the preparation of meeting agendas, key data points for discussion, and meeting minutes
- Works closely with the study team to ensure that content and results in clinical documents are accurate and compliant
- 2 – 5 years experience in a similar role
- 2 years of experience in writing Clinical Evaluation Reports (CER) or Post-Market Surveillance Reports (PMSR)
- Experience in drafting literature review and state of the art documents
- Medical Device background
- Knowledge of MEDDEV Rev 4 guidance
- Understanding of MDR (Medical Device Regulations)
If you are a Freelance Medical Writer and have upcoming availability, you can apply by:
Selecting the Apply button below or contact me directly.
I am a Clinical operations market specialist working with a large variety of clients across the Biotech, Pharmaceutical, Medical Device and CRO industries. If this role is of interest to you, or if you would like to explore other opportunities in the market, please feel free to reach out directly. Contact Joseph Sadig at 0203 545 1124 or at email@example.com.