ProClinical is recruiting for a Freelance Medical Writer Specialist on behalf of our client, a global medical device company headquartered in the US. This is a home-based position on a contract basis.
- Perform Gap Analysis
- Review existing CER with Regulatory requirements & perform Gap Analysis
- Prepare detailed Remediation Plan
- Take up Literature component separately from protocol prep to Appraisal/Analysis to Conclusion
- Review literature process outputs and Authoring appropriate sections
- Clinical Evaluation Report
- Updated CER
- Determination of Scope / Set objectives - identify the relevant ER that require clinical data (safety and performance criteria)
- Identification - identify available clinical data relevant to the device and its intended use
- Appraisal/Evaluation - in terms of its suitability for establishing the safety and performance of the device
- Analysis of Relevant Data - generate any clinical data needed to address outstanding issues
- Clinical Evaluation Report - use available clinical data to conclude safety and performance criteria are met
Education and Experience:
- Strong academic & technical background
- Advanced scientific degree in medicine - pharmacy or biology (Master of Science - Doctorate degree) completed by a specific training in clinical trials.
- More than 10 years of experience on average
- Cross-functional training
- Comprehensive understanding of regulatory guidelines (ICH-GCP, FDA, MDR & others)
- Up-to-date with various report formats as needed by Notify Bodies / Health Authorities
- Orthopedics device experience in all classes
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Valaince Penteng on +44 207 437 6824 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.