1. A CER writer will have an in-depth knowledge of medical writing and will be responsible for developing Clinical Evaluation Reports (CERs) and assessing the need for product change CERs.
2. This individual will have demonstrated expertise in partnering with clinical research, regulatory affairs, quality/reliability, product development, and bio-statisticians to develop schedules and timely execute tasks.
3. The individual will have demonstrated the ability to develop solutions to complex problems and ensures that solutions are consistent with objectives.
4. The individual will have a broad expertise in collaborating on a number of clinical and regulatory documents.
5.The role includes management of the clinical evidence report writing process to ensure compliance to regulations and expectations of Regulatory Bodies.
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