Summary: The Medical Writer will support the development and creation of regulatory, clinical and scientific documents in accordance with US FDA requirements, European Medical Device Regulations and any procedures. The two main documents they will work on are Clinical Evaluation Reports (CERs) and Summaries of Safety and Clinical Performance (SSCPs).
The Medical Writer will be responsible for:
- Researching, preparing, writing, editing and reviewing clinical evidence documents, e.g. CERs and SSCPs with minimal oversight.
- Develops and maintains in-depth therapeutic and product operation knowledge; applies this knowledge to the development of well written clinical evidence documents.
- Proofreading, editing, document formatting, review comment integration and document completion/approval activities
- Through clinical evidence document formulation and responses to regulatory agency questions, supports the regulatory approval process
The Medical Writer should have the following qualifications:
- Education and/or experience equivalent to a Bachelors' Degree in the medical, biological, physical or engineering disciplines and 3-8 years' experience writing CERs
- Knowledge of regulatory requirements relative to Clinical Evaluation Reports
- Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), EU Medical Device Regulation (2017/745) and ISO 13485 Quality System Standards.
- Experience working with class III medical devices
- Project management
If you're interested in this medical writing role, please don't wait to apply!